Dr. Paredes
is the Founder and Director of The Ellen Shaw de Paredes
Institute for Women's Imaging, Glen Allen, VA, and is a Clinical
Professor of Radiology, University of Virginia, Charlottesville,
VA. She is also a member of the Editorial Board of this
journal.
As radiologic techniques have evolved from plain films
to 3-dimensional imaging, so has the image capture format changed.
We have progressed from film-screen acquisition to
computed radiography (CR) and direct digital radiography (DR)
capture with image display and interpretation on workstations.
Because of the high resolution requirements for mammography, the
technical development in this field has been particularly
challenging and complex. Yet, now, full-field digital
mammography has been developed, tested, and approved for use in
patients and is utilized clinically. The results of the Digital
Mammographic Imaging Screening Trial (DMIST) evaluating digital
mammography in comparison to film have demonstrated its
efficacy and its value in detecting
significantly more cancers in women with dense breasts,
pre- and perimenopausal women, and in women under age 50.
1
In addition to benefits found in the DMIST, other
advantages of digital mammography in comparison to film
include technical, workflow, and interpretation aspects.
Because the 3 primary functions of image acquisition,
interpretation, and storage are separated in digital mammography,
each aspect can be optimized. Digital acquisition units have a wide
latitude that allows for the capture of information in the over-
and underpenetrated regions of the breast. Digital mammography
allows for near real-time image review by the technologist and
markedly improved throughput for image acquisition. Telemammography
and the ability to provide remote expert interpretation is possible
with digital mammography. The radiation dose is often less than
film mammography, in part because of the use of alternate
targets and filters.
In order for digital mammography to be implemented, it is
important to consider numerous practical issues, in addition to the
improved cancer detection rate. Plans must be in place for staff
and physician training, for the way in which digital equipment will
be integrated into an analog mammography department, for
connectivity and archiving of images, for the design of the reading
room to incorporate the 2 modalities, and for a new coding and
billing structure to encompass digital mammography. In addition,
how to facilitate comparison of prior film mammograms
must be considered so that the workflow in the reading
room is not compromised. This problem will diminish over time as
the digital archive is developed; at that point, the prior images
would then be retrieved from the archive and viewed on the
workstation with the current study. If a practice will retain a
combination of analog and digital equipment, an
identifiable process for triaging patients to each
modality must be determined.
In this supplement, the authors address various topics that
relate to the implementation of digital mammography in the
workplace. We offer the perspectives of the physicist,
technologist, and radiologist as well as an assessment of cost and
workflow. We will also gain perspectives on the
challenges regarding connectivity and archiving. Also, throughout
our technologic transformations, we must re-member that mammography
does not stand alone but is part of an armamentarium of other
modalities that help us to detect, assess, and diagnose breast
cancer.
REFERENCE
- Pisano ED, Gatsonis C, Hendrick E, et al, for the Digital
Mammographic Imaging Screening Trial (DMIST) Investigators Group.
Diagnostic performance of digital versus film
mammography for breast-cancer screening. N Engl J Med.2005;353:
1773-1783.
Ms. Willison
is a Consultant,
Ms. LaBella
is the Lead Digital Technologist, and
Dr. Zuley
is a Staff Radiologist at The Elizabeth Wende Breast Clinic,
Rochester, NY. Ms. Willison is also the Director of Clinical
Affairs, Koning Corporation, Rochester, NY, and Dr. Zuley is the
Chair of the IHE Mammography Working Group.
Last year, approximately 150 certified U.S.
mammography facilities closed their doors. In April 2005, there
were 9011 such centers in operation; by April 2006, that number had
decreased to 8860.
1
At the same time, however, the number of full-field
digital mammography (FFDM) systems in use increased from 819 to
1331, and the number of facilities with at least one digital system
jumped from 607 to 924.
1
Whether the decrease in the number of mammography facilities is at
crisis level or not, digital technology has the potential to
increase access and exploit existing resources.
Benefits of digital mammography
One such efficiency found with digital mammography is
the ability to perform remote reading. With telemammography,
patients can be screened at one facility while the radiologist
reads the image at a centralized site without transporting physical
films. This means that one radiologist can service a
variety of screening locations, thereby providing increased access
without increasing the number of physicians.
In addition, digital mammography offers a variety of other
advantages. One is the immediacy of the process. The button is
pushed and the image appears. The image can then be reviewed for
quality control (QC) while the patient is still in the room, and
the image can be retaken, if necessary.
Another important advantage of digital mammography is its
capacity to more clearly image dense tissue (Figure 1). The Digital
Mammography Imaging Screening Trial from the American College of
Radiology Imaging Network illustrated the value of this
technology's increased contrast resolution to better detect cancers
in subgroups of women who predominantly have dense breasts.
2
With digital mammography, the image acquisition is separate from
display, leaving unlimited access to the original image. There also
might be a reduction in the need for retakes because of incorrect
technique with digital images. In the beginning, however, this may
not be the case, as the technologist progresses through the
learning curve on the digital system. Most importantly, however,
digital data finally provides the potential to truly step
into the next generation of breast imaging. Technologies that will
likely springboard from the digital platform are computer-aided
diagnosis (CAD) and 3-dimensional imaging techniques, including
tomographic imaging (such as tomosynthesis and computed tomography
[CT]), subtraction, and dual-energy techniques.
In theory, 1 digital system can replace 2 analog units, but in
order to achieve this goal, workflow and connectivity
must be streamlined. Seemingly simple tasks can take a long time to
resolve, and, in our experience, our digital units have not been as
reliable as our analog units. There are generally fewer steps for
the technologists, less wait time for the patient, and faster
throughput-as quick as 5 minutes of room time per study, without
associated out-of-room tasks, which is the primary difference
between analog and digital. Digital mammography is predicated on
the fact that the technologist stays in, or at least very near to,
the digital room. Efficiencies can best be realized with
this approach.
Digital mammography and the technologist
Switching from analog to digital technology can seem like a
daunting prospect for the technologist, but with a little patience,
the technologist will become just as expert with digital
mammography as with analog. It is not necessary to be computer
literate to perform digital mammography; applications training will
provide the necessary groundwork to use the equipment. New users
should remain open-minded and spend time with the system. If your
facility is switching to digital slowly, get in the digital room
and use the system. The learning curve also includes the
assimilation of proper terminology in order to converse in the
language of digital mammography. For example, the terms "too light"
and "too dark" are irrelevant terms, but "signal" and "noise" are
most appropriate for the digital technology.
The digital system
In many ways, digital mammography is very similar to analog. In
other ways it is quite different. Full-field digital
mammography (FFDM) systems are composed of 3 main components: the
acquisition stand or modality, the acquisition (or modality)
workstation, and the diagnostic workstation (Figure 2). The
modality or acquisition stand is very similar to that of an analog
mammography system, with the defining difference being
the detector. In a direct radiography (DR) FFDM system, a digital
detector replaces the slotted bucky/cassette holder. The U.S. Food
and Drug Administration (FDA) recently approved a computed
radiography (CR) mammography system that uses digital cassettes
that are similar to and replace the film cassettes. The
modality workstation typically consists of a 1- or 2-mega-pixel
(MP) monitor, a keyboard, and a computer. The technologist will
perform acquisition-related tasks at the modality workstation,
including setting technique, previewing images, and archiving or
printing images. The diagnostic workstation, where the radiologist
reads the image, consists of two 5-MP monitors for image review, a
keypad to navigate the system, and, usually, a third
nondiagnostic-grade monitor for workflow. When
first approved, the FFDM systems were accompanied by a
diagnostic workstation, but more recently, the FDA has separated
these components, leaving way for mammographic images to be read on
a picture archiving and communication system (PACS) workstation.
The PACS workstation, however, must be FDA-approved to display
mammographic images.
Using digital mammography systems
The specifics of general digital technology are beyond
the scope of this article; however, several very helpful articles
on this topic have been published.
3-5
In brief, with digital imaging, the X-ray beam or photon, now
referred to as
signal
, is converted to an electronic or digital signal. As in general
digital radiography, there are 2 types of digital mammography
technology: DR and CR. With DR, there is no cassette. The breast
support holds the digital receptor, and the image is captured
directly on the unit and is ready for immediate display at the
modality workstation.
In contrast, CR technology employs cassettes that are similar to
those used in analog units, although they contain an imaging plate
instead of film. Rather than taking film from
the cassette to be developed, a CR cassette is placed in a digital
reader and the image is displayed at a workstation (Figure 3). The
workstation could be located in the mammography room or may be
shared between up to 3 examination rooms.
Although digital image capture technology is
significantly different from screen-film
technology, the clinical technologist must still balance contrast
and spatial resolution with dose and must apply appropriate
techniques in order to obtain optimal image quality for
interpretation.
There are 2 aspects of mammography interpretation: detection and
characterization. The radiologist first must be able to
detect the lesion and then be able to characterize features in
order to determine whether or not to perform a biopsy. For the
technologist, it is important to learn how the digital system works
and, when there is access to more than one mammography system, to
know which system will provide the best image for the patient being
examined. Of course, technical application is greatly
influenced by the interpreting radiologist, and the
technologist should expect a learning curve for the radiologists as
they and you learn to work-up lesions with the new technology.
Processing
The hallmark of digital imaging is that image acquisition,
processing, and display are separated. When creating an image, the
digital system first produces a raw data set, and then
electronic processing is applied. The terminology for raw data is
"for processing" and the processed image is known as "for
presentation." With early digital mammography systems, the
acquisition stand provided the raw data and sent it to the
diagnostic workstation to be processed. In the newer FFDM systems,
the processing function has been moved to the acquisition
stand.
Processing algorithms, which are then applied to the "for
processing" data, optimize the presentation state of the image.
While processing improves the display and makes the image more
pleasing to the eye, processing cannot add information to the
image. Currently, each FFDM vendor has its own proprietary
algorithm, all of which are continuing to evolve. This will be the
status quo for a few years, but in my opinion, we may be moving
toward a system that employs processing boxes to which all raw data
will be sent, regardless of origin, and all images will be
processed in a consistent manner that will likely be chosen by the
primary interpreting radiologist(s).
Image acquisition and display
Digital detector
It is important to understand the origin of the digital image in
order to properly apply technical factors. A digital acquisition
platform is made up of small elements called pixels (or detector
elements), which are arranged in a square or rectangular shape
(Figure 4) referred to as a matrix. The space between the pixels is
known as the pixel pitch. The size, pixel pitch, and arrangement of
the pixels in the matrix provide for the spatial resolution of a
system. Pixels also have bit depth (think of them as "wells" that
fill up with X-ray photons). The bit depth of the pixel
determines the number of shades of gray, which, in turn, provides
the level of contrast resolution or-in digital speak-dynamic range.
These factors are the essence of a digital receptor and, just like
a screen-film combination, have characteristics that are
unique to each detector. The FFDM systems in use today have
detectors with pixel sizes ranging from 25 µm to 100 µm. As pixel
size decreases, spatial resolution increases, but so do noise,
radiation dose, and storage requirements.
Looking at different matrices (Figure 5), one can see that,
given the same bit depth, as the pixels get smaller and the number
increases, the amount of information also increases. It is
important to reiterate that as pixel size decreases, resolution
will increase, but so will the noise and the dose factor.
Manufacturers have carefully balanced pixel size and matrix in
consideration of these factors.
Technical applications
Digital mammography has a new set of parameters for technical
application. The technologist will no longer think in terms of
mAs
and
kVp
but in terms of
signal
and
noise
and the ratio between the two. Signal is the X-ray photons coming
out of the tube. Noise is anything that interferes with the
visibility of useful signal and includes quantum noise or mottle as
well as electronic noise, a constant presence in digital receptors.
Detective quantum efficiency (DQE), which is expressed as
a percentage, is the ability of a system to detect and use exiting
X-ray photons (the signal). In theory, the greater the DQE, the
less signal (dose) is needed.
The goal of technical application is to achieve adequate signal
to fill the pixels and overcome existing electronic
noise, without overfilling. While the beauty of a digital
image is that display is separate from acquisition, this also adds
difficulty in evaluating the quality of an image, as at
first glance, a digital image will always look "good."
Under- and overexposure will not result in a "dark" or "light"
image, but may result in a noisier image in the case of
underexposure or poor contrast in the case of overexposure. Figure
6A shows an overexposed image, and Figure 6B shows the same image
at the correct exposure; notice how flat in contrast the
overexposed image appears. This will not be able to be made better
with windows and leveling. Note how more calcifications
are apparent in the correctly exposed image. Note also the increase
in noise in the "correctly" exposed image.
The technologist will adjust mAs and kVp as a means to achieve
adequate signal-to-noise ratio. Kilovoltage no longer has a great
effect on image contrast but rather will be used to boost signal
because image contrast is largely dependent on the dynamic range of
the digital detector and the digital imaging chain. With digital
technology, adequate exposure is measured with analog-to-digital
units (ADUs) or exposure index (EI). Ranges for adequate exposure
are provided by each manufacturer, and digital automatic exposure
controls (AECs) allow for excellent exposure control. The
technologist should understand that the entire detector or imaging
plate is used for exposure control, in contrast to analog imaging,
in which just a small, usually central phototiming detector was
employed.
Patient positioning
The primary difference between FFDM and analog positioning is
that the technologist has only one surface on which to position all
breast and patient sizes. In addition, the digital detector is
thicker, which means it is a little more difficult to
accommodate a large abdomen and other more difficult body
habitus. A positive aspect of the DR detectors is that the entire
image receptor area acts as a digital AEC, which means that the
breast does not have to be centered over a photocell. This allows a
smaller breast to be positioned higher up on the image receptor for
adequate positioning.
Image display options
Once the image is acquired and processed, it is typically
displayed on monitors (however, in some situations, digital images
may be printed to film for interpretation). Typically,
the data is acquired at an acquisition matrix size of approximately
20,000,000 pixels in roughly a 10 × 12-inch matrix. The display
(monitor) technology displays only 1 to 5 million pixels. What this
means is that an entire image cannot be fully displayed on one
monitor at full resolution. For this reason, soft copy workstations
provide 3 ways for the images to be displayed. One option is called
"fit to screen," in which the information is downsized to
fit to any window in which it is displayed. A second
option is "true size," which displays the image using the true size
of the breast. Both options do not display the full data set of the
digital image. A "pixel-to-pixel" or full-resolution display is the
only display option that provides the entire data set. One issue
that still needs to be addressed by FFDM manufacturers is the
display monitor at the acquisition workstation. The acquisition
workstation monitors are approximately 25 inches on the diagonal,
with just 1 to 2 million pixels. This makes it more
difficult for the technologist who must display the image
in pixel-to-pixel mode and spend time panning the image to detect
motion.
Quality control
Detecting motion
At our facility, the technologists reported that it was
difficult to detect motion on the 2-MP QC monitors in the
imaging room. When we looked carefully at this issue, we found that
the problem wasn't in detecting motion, but more in
confirming that there was no motion. On the 2-MP
monitors, many images look somewhat fuzzy, although they appear
smooth on the radiologists' 5-MP monitor. One way to address this
is to display the image using pixel-to-pixel resolution and check
for gross motion.
Artifacts
As with analog imaging, artifacts can occur with digital
mammography. Digital mammography artifacts are not yet widely
understood and can be a time-consuming problem to resolve. Some
artifacts may be very subtle, but they can have a dramatic effect.
Artifacts arise from the detector, processing, and the monitor as
well as the X-ray tube, filter, and grid.
The radiologist has a higher-resolution monitor and may see
artifacts more readily than the technologist. Monitor artifacts can
be particularly difficult because the technologists and
the radiologists are viewing the image on different monitors.
Therefore, an artifact on the radiologists' 5-MP monitor will not
appear on the 2-MP monitor that the technologist used to perform
the QC.
DR FFDM systems directly convert X-ray to digital signal. Such
units may exhibit trouble in completely clearing the imaging
detector of the previous image or images, which can result in
"ghosting" artifacts (Figure 7). It is not clear at what level
ghosting noise interferes with the diagnostic quality of an image,
if at all. The image displayed in Figure 7 was acquired using the
QC flat-field phantom. Outlines of previous
mammogram images are visible as a ghosting artifact. The ghosting
may get worse with detector age, as was the case with this early
version of a DR detector, which had to be replaced.
Quality assurance
Quality assurance measures for digital mammography are still
evolving. Currently, system testing is conducted using
manufacturing paradigms that are ap-proved by the Mammography
Quality Standards Act (MQSA) for each individual vendor's system,
but the American College of Radiology (ACR) is working on
developing a uniform set of standard tests for all systems. All
parts of the digital unit must undergo quality assurance, including
the diagnostic workstation, the acquisition workstation, the
acquisition stand, and the printer.
System servicing
Servicing of FFDM systems is vastly different from that of
analog systems, and this has both advantages and disadvantages.
Some servicing issues can be worked out over the phone, thereby
eliminating downtime while awaiting the arrival of a service
technician. The downside to this is that the technologist, in
effect, becomes the service person, often working in tandem with a
technician on the phone. Therefore, it is very important to have a
phone, preferably a cordless one or one with a very long cord, in
the digital room.
Another advantage to servicing an FFDM system is the ability to
conduct remote dial-in servicing. This means that the servicing
company can sometimes diagnose and rectify a problem remotely
through a modem or virtual private network.
Field service engineers and technologists are on a learning
curve for troubleshooting, and the technologist and service person
may need to work together to determine the cause of a problem.
Historically, service engineers have been mechanically oriented.
Now, with the new technology, they must be more computer savvy. If
you have the first digital system in your area, it's
likely that you're going to be on the learning curve for that
service engineer.
Servicing and performing quality assurance testing of FFDM
systems may also be a matter of geography. The diagnostic
workstation will be remote to the acquisition stand, and a printer
may be in a third location, yet all of these components must be
tested, maintained, and documented according to MQSA standards.
Conclusion
The promise of digital mammography lies not in the use of the
abundant data set to produce a 2-dimensional image, but in the
ability of FFDM to take us to the next generation of breast
imaging, including tomosynthesis, CT mammography, contrast-enhanced
subtraction mammography, CAD, and, eventually, less invasive
methods of biopsy and treatment of breast cancer, blurring the
lines between diagnosis and treatment.
For the technologist, however, although the tools may change,
their primary job is that of listening to and forming a
relationship with the patient, in order to provide the best images
and pertinent information for interpretation. That does not, and
will not, change with digital mammography or any other new
technology.
REFERENCES
- United States Food and Drug Administration Center for Devices
and Radiological Health. Mammography: MQSA Facility Score Card.
Available online at:
http://www.fda.gov/CDRH/MAM-MOGRAPHY/scorecard-statistics.html.
Accessed April 15, 2006.
- Pisano ED, Gatsonis C, Hendrick E, et al. Diagnostic
performance of digital versus filn mammography for
breast-cancer screening.N Engl J Med. 2005;353: 1773-1783;
comments in: N Engl J Med. 2005;353: 1846-1847 and N Engl J Med.
2006;354:765-767; author reply: 765-767.
- Balter S. Fundamental properties of digital
images.RadioGraphics. 1993; 13:129-141.
- Pisano ED, Cole EB, Hemminger BM, et al. Image processing
algorithms for digital mammography: A pictorial essay.
RadioGraphics. 2000;20: 1479-1491.
- Pisano ED, Yaffe MJ. Digital mammography. Radiology.
2005;234:353-362.
Dr. Seibert
is a Professor of Radiology at the University of California,
Davis Medical Center, Sacramento, CA.
At the University of California, Davis (UC Davis), we had the
opportunity to participate in the Digital Mammographic Imaging
Screening Trial (DMIST).
1
As part of this trial, we imaged approximately 3000 women using a
prototype of the Fuji FCR 5000MA digital mammography system (now
commercially available as the ClearView-CS
m
and the ClearView l
m,
FUJIFILM Medical Systems USA, Inc., Stamford, CT). This article
reviews our 2-year experience using this system as part of this
major study.
Benefits of digital mammography
Converting from screen-film to digital mammography
offers several advantages. One of the most important advantages is
the ability to overcome the limitations of analog
mammography-specifically, the limited exposure latitude
caused by the need for high contrast to detect subtle lesions in
the breast. For dense, thick breasts, the transmitted exposure
covers a much greater range than does the screen-film
latitude, causing overexposure in thin areas of the breast near the
skin line, and underexposure in the highly attenuating glandular
tissues, causing the loss of anatomical detail and contrast.
Digital detectors used for mammography have a wide-latitude
response that can capture the X-ray information in the over- and
underpenetrated regions and provide excellent contrast by digital
image postprocessing enhancement methods. In addition, digital
imaging provides the opportunity to advance processing techniques
that may reveal additional information not seen on film;
it can also easily perform a "second read" using computer-aided
detection (CAD). Digital technology also facilitates remote
diagnosis. With telemammography, images acquired at a remote
imaging center can be transmitted electronically to a central
location for diagnosis or consultation. Reduced image handling and
electronic storage and retrieval also greatly improve
workflow.
Digital mammography provides an extended dynamic range
(latitude) as a result of the way the image information is acquired
on the digital detector and converted into a digital number.
Screen-film detectors have extremely narrow latitude
because of the need to have high contrast (optical density
differences) to obtain a small difference in transmitted
exposure--these factors are related because the film is
both the acquisition and display medium. Often, the densest areas
of the breast image are underexposed, and the most highly
transmitted areas near the skin line are overexposed. Digital
systems, on the other hand, have the acquisition and display
decoupled, allowing for image postprocessing for image contrast and
resolution enhancement, limited only by the signal-to-noise ratio
of the image itself. Thus, processing can be applied to the digital
mammography image to provide image information for the densest
regions of the breast while also evaluating the anatomy at the skin
line and peripheral areas.
For the radiologist interpreting the images, however, digital
processing initially presents challenges because of a completely
different presentation and look relative to the
screen-film images, which makes longitudinal comparisons
initially difficult. For those converting to digital
mammography, this is certainly an issue that must be dealt with
carefully during what can be a relatively long transition from
analog to digital. On the other hand, because of the
flexibility of postprocessing, the radiologist can
develop a greater confidence in the interpretation of the
difficult cases that are suboptimally presented on
film.
CR versus DR
Currently, there are 2 types of digital mammography systems
available in the United States: computed radiography (CR) and
digital radiography (DR). A CR system was recently approved by the
U.S. Food and Drug Administration (FDA) for use in breast imaging.
With CR systems, the X-rays transmitted through the breast,
antiscatter grid, and cassette cover are absorbed by the CR imaging
plate, a photostimulable storage phosphor (PSP). Locally absorbed
X-ray energy corresponding to anatomical variations in the breast
produces an electronic latent image on the PSP. Subsequently, the
cassette is removed from the mammography stand and is placed in a
CR reader where a scanning laser beam stimulates the release of
light that corresponds to the incident X-ray intensity. The light
information is captured, converted to a digital signal, and
displayed at the workstation (Figure 1). With DR, the X-ray signal
is converted directly to a digital signal at the acquisition stand
in the detector and no cassette is used. The image is displayed at
the workstation shortly after it is acquired.
Using a CR system
With CR, the image acquisition process is nearly identical to
that used with analog mammography. The CR cassettes are identical
in size and function to screen-film cassettes (18 × 24 cm
and24 × 30 cm), and the image acquisition device is set in the
conventional way to the required size that best matches the breast
size. This means that the technologist does not need to image a
small breast on a large panel or image a large breast on a small
panel and "tile" the images to obtain a complete breast
examination. Once the image is taken, the cassette is removed from
the acquisition stand and is placed in a digital reader and
processed before the image can be viewed. Each image is then viewed
by the technologist at the quality control (QC) workstation to
ensure proper imaging, including appropriate positioning, lack of
motion, etc.
When dedicated CR mammography was first tested in the
United States under a research protocol approximately 5 years ago,
the detector system was simply a high-resolution imaging plate with
specialized cassettes for mammography that used conventional CR
readers. However, since then, CR mammography systems that are
nearing market approval have improved with the introduction of
finer sampling (50-µm laser spot size) and the ability to
collect more light from the photostimulated luminescence (PSL)
process using 2 light-channeling guides. The readout is tuned for
high resolution and low noise, both of which are extremely
important in digital mammography.
In clinical operation, CR mammography is very similar to
screen-film mammography. One difference is the increased
X-ray absorption of the CR cassette and imaging plate by 20% to 30%
more compared with a screen-film detector. Acquiring
images at approximately the same dose in the DMIST study required
an adjustment of the automatic exposure control (AEC) sensitivity
by a similar amount, as the AEC detector is positioned underneath
the cassette. The solution was to use the density selector switch
at the "-2" position (each position changes exposure typically by
12% to 15%) for the CR cassette, and the "0" position (as
calibrated) for the screen-film cassette. For the "-2"
setting, the electronics for the AEC system turned off the X-rays
at the appropriate time to achieve approximately the same average
glandular dose to the breast. In terms of acquisition techniques,
the X-ray generator selected the "optimal" kVp and attenuation
filter (either molybdenum or rhodium) using a brief
test-shot method to evaluate the penetrability of the breast and
algorithms tuned for screen-film response. In most cases,
the techniques used for screen-film and CR cassettes were
within 1 kV and ±10% of the mAs, although occasionally there was a
greater difference (usually the CR system would drive the kV higher
and mAs lower). Certainly, for a system tuned for dedicated digital
acquisition, in all likelihood a slightly increased kVp and lower
mAs could be used to reduce breast dose without a loss of image
quality.
Originally, CR cassettes for mammography were designed with
single-sided readout. The recent introduction of dual-sided imaging
plates and reader systems allows a more efficient
collection of photostimulated light from the laser beam by
providing light collection from both the front and back sides of
the imaging plate. Functionally, the cassette is used in the same
way as a single-sided CR cassette. The imaging plate itself is
composed of the PSP material layered on an optically transparent
support. After exposure, the cassette is placed into the reader,
the imaging plate is extracted and translated through an optical
stage (Figure 2), and PSL is generated from the laser beam in both
the forward and backward directions. Light collection guides are
positioned above and below the imaging plate to capture and measure
the light intensity, which is then amplified and
converted to a digital number that is proportional to the X-rays
absorbed on the plate at that position. Positional information is
determined by the location of the plate in the translation stage
direction and the position of the mirrors for the laser beam scan
direction. There are differences in the characteristics of the
information acquired from the front and back light guides.
Sophisticated signal-processing algorithms are applied to the
separate signals to optimize the characteristics of spatial
resolution and contrast resolution, which are then combined at the
image processor to produce the final output image. The
read-out, which occurs as a result of the laser beam scanning the
plate in raster fashion, takes approximately 60 to 75 seconds to
complete. The cassette is then erased and reused.
In our experience with CR, we have found that when an area of
the imaging plate is overexposed, the raw radiation on the imaging
plate is recognized by the reader, and a longer erasure cycle is
implemented. It is important for all residual, latent image centers
to be eliminated during the erasure process. In some cases, this
can take as long as the time required for readout, but it is
necessary in order to avoid ghosting artifacts in subsequent
images.
Spatial resolution
The effective resolution of screen-film mammography is
approximately 25 µm, equivalent to 20 line pairs per mm sampling in
a digital detector. To be equivalent, a digital detector for a
single 18 × 24-cm image would result in 140 mega-bytes (MB) of
data-obviously way too much. Using 50-µm pixels, about 16 million
individual detector element values are output to the display, with
each image made up of approximately 32 MB of data. Systems that use
100-µm pixels produce 8-MB images for an 18 × 24-cm field
of view.
How does spatial resolution impact information transfer in terms
of element size? If an object is larger than the detector element,
a faithful representation will be obtained. On the other hand, if
an object, such as a microcalcification, is smaller than
the detector element, the information content will be blurred over
the detector element area. The modulation transfer function (MTF)
(Figure 3A) illustrates how information is lost as a function of
spatial frequency (inverse of object size); a perfect system would
deliver 100% modulation for all spatial frequencies. The cutoff
frequency (maximum spatial frequency contained in a signal averaged
over an area) for a 50-µm element size is 20 line pairs per mm.
Depending on the sampling pitch (distance between sample areas),
the Nyquist frequency (maximum useful frequency) when the sampling
pitch equals the aperture dimension (the situation for most digital
detectors) is equal to half the cutoff frequency (known as the
Nyquist sampling theorem), meaning that 10 line pairs per mm is the
maximum useable frequency in the acquired image for a 50-µm spot
dimension.
In reality, when one compares the hypothetical perfect detector
to actual CR measurements, it is clear that the MTF does fall off
significantly at higher spatial frequencies (smaller
object size) as shown in Figure 3B. This is chiefly
because of PSL light spread during acquisition of the latent image
in the CR reader. When considering the cutoff frequency, Nyquist
frequency, and transmitted detail resolution, however, it is
important to consider what happens at all resolutions. The MTF
shows that data. There is a loss of modulation due to
light-scattering events, but high-contrast objects such as
microcalcifications provide sufficient signal
modulation to still be detected reasonably well with CR.
Detective quantum efficiency
Detective quantum efficiency (DQE) is the percentage
of information content available to the detector that is actually
used and preserved in the image, and, like MTF, is a function of
spatial frequency. As shown in Table 1, when using a dual readout
detector, the DQE is higher for CR than for a corresponding
screen-film detector. This is because of the higher
absorption efficiency of CR and a lack of grain noise,
which is a problem with film. Compared with DR, CR has a
lower DQE, and a slightly higher exposure is necessary to achieve
the same signal-to-noise ratio in the breast image.
Image noise sources (other than X-ray quantum noise) that can
decrease the DQE include luminescence noise (X-ray to light
variation), pattern noise (readout, raster scan, grid signals),
background noise (sensitivity, offset variation), and structure
noise (detector, equipment artifacts).
With CR, structure noise such as variations in the
light-channeling guide response can produce a nonuniform output
image (often called "shading"). Shading corrections (measuring the
response with a uniform field and creating an inverse
pattern that cancels the fixed patterns) will improve DQE
significantly. This is implemented as a 1-dimensional
correction algorithm along the path of the laser beam scan. One of
the things that CR does not do, at least with current technology
for breast imaging, is a 2-dimensional (2D)
"flat-field" correction to compensate for
consistent variations such as the heel effect, which large-area,
flat-panel detectors can provide because of the
fixed geometry of the source and detector positions.
With regard to data manipulation and image preprocessing,
besides correction for variations in shading, for dual-sided
readout the front and the back responses of the imaging plate are
"weighted" to optimize image quality, considering the propagation
differences of light that is transmitted versus
reflected. This plays an important part in maintaining
good spatial resolution and keeping the noise as low as
practical.
CR versus screen-film mammography
There are several potential advantages of CR compared with
screen-film mammography. One is the higher DQE associated
with the digital technology that allows the CR system to provide a
higher signal-to-noise ratio at similar or lower radiation doses
than an analog system. Digital imaging also facilitates additional
image processing and CAD evaluation. In addition, CR offers more
consistent image quality with minimal artifacts (unlike the common
wet processing artifacts and variation in processing chemistry). In
our experience, we also found that we had fewer retakes with the CR
system compared with the analog units, chiefly because of
under/overexposure situations that require screen-film
retake but are not a problem for the CR system because of its
ability to compensate through postprocessing methods.
On the downside, the prototype CR system we used in the DMIST
trial required a longer processing time than screen-film
mammography, chiefly because of the single-plate reader
that was used in a batch mode, requiring the technologist to insert
each cassette one by one and to wait for the readout and erasure
before the next imaging plate could be inserted. (The commercially
available system has 4 cassette slots.) Also, in the trial,
screen-film images were acquired in addition to laser
printing the digital images, adding another (slow) step to the
process (both of which would be avoided in a clinical production
unit using soft-copy display). In addition, there was some loss of
detail for the smallest microcalcifications that could be
appreciated on screen-film that were often not clearly
seen on CR images because of the lack of signal modulation at the
intermediate-to-high spatial frequencies. Finally, not unlike any
other digital system, the use of CR also requires the radiologist
to become familiar with the image characteristics of digital
mammography.
CR versus DR
When comparing CR with DR, there are also some potential
advantages to CR. First, CR is less expensive to implement.
Existing mammography systems can be converted to digital with just
the addition of CR cassettes and a CR reader tuned for mammography.
In addition, with the purchase of one high-throughput centralized
reader, facilities can convert several mammography rooms to digital
technology without replacing substantial amounts of equipment.
Computed radiography also offers 2 detector sizes for optimal
positioning of small or large breasts, whereas DR offers only a
single detector size that often compromises positioning or requires
a tile-mode acquisition. The acquisition process of CR is very
similar to that of analog mammography, so the technicians and
radiologists do not need to learn new acquisition techniques.
The disadvantages of CR as compared with DR include the need for
significant handling of CR plates/cassettes and the delay
in image display as the plates are processed. In contrast, DR
systems produce an image within seconds, which allows the
technologist to immediately perform quality control on the image
for positioning, motion, and other issues, and if necessary,
perform a retake before moving to the next projection. Technique
information from the X-ray generator (kVp/mAs/focal spot size, tube
target, tube filter, acquisition algorithm, AEC "density"
setting, etc.) and peripheral devices (compression thickness, use
of grid, AEC detector position, etc.) require a
modification/interface to the mammography system to
download information to the DICOM header of the digital mammography
image prior to sending it to the dedicated mammography workstation
or universal DICOM-compliant picture archiving and communication
system (PACS). Another potential disadvantage is the lower
signal-to-noise ratio for the same breast dose because of lower DQE
and the slightly lower intrinsic resolution of the CR system
relative to the flat-panel detectors designed for
mammography.
Workflow also can be a concern with the CR system
because of the processing requirements; historically, all 4
screening views were acquired and the technologist left the room to
process the images. One way to address this issue is to have an
"in-room single-plate reader." This provides the ability to process
one view while setting up for the next view so that at the end of
the examination, there will be only one imaging plate left to read
out. This can enhance the throughput and make it easier to keep up
with the workflow in a busy room. The downside is the
need to buy an in-room reader for each digital system, with
increased costs for implementation compared with a single
high-throughput stacker in a facility with multiple digital
mammography rooms.
Looking forward
At UC Davis, our experience with the prototype CR mammography
unit was mainly positive, based on the quality of the digital
images, the ease of implementing the CR detectors with our existing
mammography systems, and the fact that we did not experience any
technical problems with the CR reader in performing approximately
3000 studies (including a lot of QC testing) in >2 years of
operation. We would have preferred not having to print
film (but that was part of the study protocol), and the
slowness of the prototype system (at least in batch-mode
processing) was of concern.
As digital mammography continues to evolve, there are several
enhancements that could be made to increase the
efficiency of CR systems. The addition of an in-room
single-plate reader (which is now available) would boost
workflow by allowing the technologist to remain in the
room during the entire examination. Alternatively, a batch-mode
process would certainly indicate the need for a multiplate reader
system. Workflow could also be enhanced by the addition
of an equipment interface for X-ray technique information. Finally,
the adoption of normalized, linear "for processing" image data
standards would allow users to compare all digital systems
equitably.
The conclusion of the DMIST study unequivocally supported the
superiority of digital mammography over screen-film
1
and portends the adoption of digital mammography in lieu of
screen-film with increasing frequency. This increasing
implemenation will continue despite some of the hurdles that must
be overcome in transitioning from an analog to digital environment,
including cost and reimbursement issues, hybrid digital and analog
reading for a period of time, workflow optimization, and
image appearance differences among the digital mammography systems.
At the time of this writing, the Fuji CR mammography system was
just FDA-approved for clinical imaging. Without a doubt, the system
will fill a large niche in the digital mammography
market, as there is a demand for a capable, cost-effective
technology that delivers excellent image quality.
Acknowledgments
The author wishes to acknowledge FUJIFILM Medical Systems USA,
Inc. for providing the digital mammography system used at UC Davis
for the DMIST study and for information on workflow.
This article was supported, in part, by the ACRIN DMIST grant at
UC Davis (Karen Lindfors, MD, Principal Investigator at UC Davis).
The author also thanks Martin Yaffe, PhD, Physics Core leader,
DMIST study and implementer of QC phantom tools/software.
REFERENCE
- Pisano ED, Gatsonis C, Hendrick E, et al. Diagnostic
performance of digital versus film mammography for
breast-cancer screening. N Engl J Med. 2005;353:1773-1783.
Dr. Newstead
is a Professor of Radiology and the Clinical Director of Breast
Imaging at the University of Chicago, Chicago, IL.
More than 276,000 new cases of breast cancer will be diagnosed
this year.
1
Of those, roughly 212,000 will be invasive cancers and 62,000 will
be ductal carcinoma in situ (DCIS). Approximately 41,000 American
women and 460 men die of breast cancer annually. At present, there
are >2 million U.S. women living with a diagnosis of breast
cancer. In recent years, the death rate for breast cancer has
steadily decreased, although the incidence has continued to
increase. This trend toward earlier diagnosis and increased
survival is often attributed to the effectiveness of screening
mammography programs.
2-4
Each year, approximately 1 million additional women enter the
screening age group. In 1999, approximately 42 million mammograms
were performed in the United States. The following year, 44.5
million mammograms were done, and by 2004, that number jumped to 49
million.
2-4
As the baby boom generation continues to age, this number will only
increase. It is estimated that there were approximately 70 million
women over the age of 40 in the United States in 2005 and that, by
2025, the number will increase to >88 million.
5
The cost for screening all of these women can be
significant. Approximately 49 million women will undergo
screening mammography this year. Of those 49 million, roughly 10%
will be called back for additional workup, such as diagnostic
mammography, ultrasound, or magnetic resonance (MR) imaging. Of the
women who go on to diagnosis, many of them (65%) will be found to
be cancer free. They will all have undergone diagnostic
mammography, some will have ultrasound, and a small percentage will
have MRI. Approximately 36 million of the 49 million women screened
will be truly healthy, but there will still be approximately 40,000
cancers not detected at mammography. The direct cost of screening
alone is estimated to be $2 billion a year, with the follow-up
examinations adding another $1 billion.
As the demand for breast imaging services continues to increase,
the resources to provide these services continues to decrease. A
1995 survey found that only 3% of all radiologists actually
specialized in breast imaging.
4,6
In addition, there is a shortage of breast imaging fellowships
nationally and a decreasing number of applicants to these
fellowships, meaning that we are not training enough breast
specialists for the future. There is also a shortage of breast
imaging technologists in various parts of the country, and burn-out
(due to the increasing workload) among the present staff can be a
problem. If the average volume of mammograms that are currently
read by interpreting physicians were to remain constant, then a 38%
increase in the number of radiologists would be needed by the year
2025 in order to meet the demand for screening mammography.
The economics of breast imaging
What is the basic economic situation in the typical breast
imaging practice? The American College of Radiology (ACR) conducted
a survey that studied what it costs to perform a mammogram either
in a hospital or an outpatient setting, not including the
physician's fee for interpretation. For the hospital practice, they
found that the actual cost to perform a screening mammogram was
$93.98. With typical reimbursement of approximately $80, it is
clear that the hospital lost money for each screening exam
performed.
In the outpatient setting, where the costs can be more
controlled, the survey found the cost per mammogram to be
approximately $59.00. Nonetheless, it is clear that there are no
large profits to be made from screening mammography.
Another economic study analyzed professional income at 7
geographically representative academic programs in the United
States.
7
For this study, the researcher took the revenue and subtracted from
it the direct costs (salaries of the physicians, fellows,
malpractice insurance, and secretarial and other assistance) and
indirect expenses (such as billing expenses) to determine
mammography's contribution margin. The study found that in all
practices mammography had a negative profit margin. The
loss for physician full-time equivalent (FTE) was variable between
the practices studied but was between $50,000 and $100,000 per
year. The author also found that diagnostic mammography was the
driver of this loss because of the increased physician time and
personal involvement in such cases. He concluded that a 3-fold
increase in reimbursement for diagnostic mammography was needed
just for breast imaging practices to break even.
Making mammography more efficient
As part of the previously mentioned study, an activity-based
cost analysis was performed using a time-motion study.
7
In this part of the study, the radiologist was followed by an
observer with a stopwatch who would clock exactly how much time the
physician spent doing each task. The researchers calculated that
for each screening examination, a total of 5 minutes of physician
time was involved for all activities, including not just diagnostic
reading but quality assurance (QA), comparisons to prior images,
and all other activities performed by the radiologist. The study
also found that diagnostic mammography and ultrasound each required
25 minutes of physician time, as did consultations. Interventional
procedures took roughly 60 minutes.
Compliance with unfunded federal mandates can also affect a
practice's bottom line. One study at a large East Coast practice
found that it cost $7.82 per patient to comply with federal
mandates such as MQSA regulations, etc. (Destouet JM, personal
communication). This can be a significant burden,
particularly when the reimbursement rate is only approximately
$80.
Digital mammography
Will converting to digital mammography help the bottom line? I
believe that whether it helps or not, we are going to have to do
it. It is essential-especially for practices that are based in
multimodality, multisite facilities-for mammography to move into
the digital arena. Therefore, the question really is how we can
convert to digital and be cost-effective?
Digital mammography can be beneficial to routine
practice. It provides for the rapid review of images, it decreases
the time required for the technologists to acquire and process the
images, and it allows for immediate repositioning and image retakes
when necessary. The real-time image display capabilities of digital
mammography also increase patient throughput by eliminating
film processing and its associated costs, and digital
technology expedites all work-ups and interventional
procedures.
The teleradiology applications of digital mammography can also
be beneficial. Centralization of screening
interpretations can address both cost and personnel shortage
issues. Second-opinion services and conferences, as well as
computer-aided detection (CAD) services, can also be facilitated
using digital technology. Given the shortage of radiologists, it
would be very helpful if screening images were acquired at remote
sites and then electronically sent to a central location for
reading by a radiologist who specializes in breast imaging. It is
possible that diagnostic examinations could be performed remotely
as well, with the radiologist at the interpretation workstation
site and the technologist at the location where the image is being
acquired. With real-time synchronization between the technologist
and the radiologist, diagnostic procedures could, theoretically, be
performed remotely.
What about the physician interpretation time? At New York
University, we investigated that when we first began
using digital mammography roughly 5 years ago.
8
We evaluated the time spent by both the physician and the
technologist when performing a digital mammography examination
compared with the time spent on an analog study. The technologist
imaged 100 patients with a 2-view digital screening exam. An
additional 100 patients underwent a standard 2-view analog exam. A
stopwatch was used to monitor the time spent by the technologist
performing the examination, interacting with the patient, and
checking the images. The physician time for viewing and decision
making was recorded with the stopwatch, but not the reporting
time.
We found that the technologist time was reduced from 10 minutes,
29 seconds for an analog examination to 6 minutes, 12 seconds for a
digital examination, saving more than 4 minutes of technologist
time per patient. The physicians, however, took longer with the
digital images, going from 25.8 seconds per analog study to 76
seconds per digital study. One of the reasons for this increase in
reading time was the need to compare the new digital images with
the prior film mammograms and the need for panning and
other image manipulations with the digital technology.
One of the concerns with the conversion to digital technology is
the large initial expenditure required to make the switch. It is
estimated that it takes 5 years to net the present value of the
costs associated with converting to digital.
As for reimbursement, private insurers vary in adopting Medicare
reimbursement rates for mammography. There are still some states in
which getting paid for digital mammography is a problem and others
in which the reimbursement for digital is higher than for analog.
It is not uniform across the country. This can affect the bottom
line. It has been estimated that full-field digital
mammography (FFDM) must have a 50% adoption rate by insurers and be
used at 90% capacity in order to be profitable.
Strategies for survival
As the demand for services increases and the available personnel
and resources diminish, radiologists in general and breast imagers
in particular are going to have to increase productivity.
Teleradiology with image reading performed overseas is helpful, but
the bottom line is that radiologists are going to have to work
harder and be more efficient. If we are unable to keep up
with the imaging demands of our patients, we risk losing some of
the market to nonradiologists.
Increased productivity will not work, however, if a practice's
profit margin is negative. One way to help address this
issue is to separate screening and diagnostic cost centers. Online
evaluations and procedure scheduling should all be part of the
diagnostic arena. Fast interpretation of screening examinations is
helpful, and automated reporting and reduced paperwork are both
very important.
It is also important that the technologists, many of whom are
already assuming a significant responsibility in helping
us care for our patients, have a pathway for increased
responsibility. It is certainly possible for technologists who wish
to proceed up the ladder to perform tasks that are currently
performed by physicians and to aid physicians in conducting
diagnostic workups. The specifics of how this can be done
are beyond the scope of this article, but I certainly think that it
is important for the breast imaging community to retain motivated,
excellent technologists.
The technologist must be able to focus on patient care. The
presence of a technologist's aide who can perform such duties as
greeting the patient and escorting her to the changing area can be
very helpful. Technologists should not be spending valuable time
assembling the charts, processing and hanging films,
setting up rooms, and folding laundry. These are all things that
can be done by a technologist's aide, leaving the technologist free
to focus on patient care and the imaging aspect of the process
only.
Information integration
If breast imaging is going to survive and be economically
viable, it must become filmless and paperless. Seamless
integration is an important concern when attempting to achieve this
goal. Currently, we all have separate systems; we have multiple
information systems from multiple vendors. We do not have one
"whole" that is integrated and organized. We need to drive the
standards toward problem solving and toward integration
profiles in radiology and across the healthcare
institutions.
The Integrating the Healthcare Enterprise (IHE) initiative is
working toward the goal of uniform "plug-and-play" operations for
all clinical information systems from all vendors and across all
modalities. The purpose of this multiyear, multistakeholder,
inter-operability initiative is to move beyond simple Digital
Imaging and Communications in Medicine (DICOM) standards and
harness all existing healthcare and information technology (IT)
standards to produce technical recipes, called "integration
profiles" for how these standards should be implemented.
To say a system is DICOM-compatible is only a first step;
it does not necessarily mean that all of the information is being
integrated into a form that the radiologist can use, thus becoming
more efficient. That is the purpose of IHE.
What can an individual radiology department do to improve
information workflow? First, it's important to identify
the core functions of each system within the department. Then
determine what is needed to communicate between these different
systems. How does the mammography workstation talk to the MR
workstation? What images are on the MR report and how can they be
pulled up and viewed at the workstation?
For efficient workflow, we need
efficient modality acquisition and a scheduled
workflow integration profile. Most departments
have a radiology information system (RIS), a hospital information
system (HIS), a picture archiving communication system (PACS), and
more, but these systems don't always communicate with each other
efficiently. In addition to managing and archiving
images, we need to be able to efficiently and accurately
move all of the relevant data (including patient registration
information, order placement, and filing) throughout the
entire enterprise.
Issues regarding CAD results and information storage still need
to be addressed as well. Should CAD marks be stored? Should the
modality automatically push the CAD results to the workstation?
Should both the "for processing" and "for presentation" image data
be archived? Are there liability issues that need to be considered
with regard to information storage? These issues still need to be
addressed as mammography services migrate to digital
technology.
The key to success in all of these issues lies in the design of
the workstation. Workstations must become vendor-neutral and
multimodality-capable. Computer-aided detection must also become an
essential part of any workstation. As we deal with ever increasing
data-sets from mammographic, ultrasound, and MR images, CAD will be
a vital part of this interpretation.
Patients expect access to high-quality mammography; they want to
be educated concerning screening and abnormal findings.
They also want the latest equipment. They want digital mammography,
and they want high-tech MR studies. Coordination of all imaging
studies must be a priority for all breast imagers.
Conclusion
We are at the crossroads in the transition from analog to
digital breast imaging. Ultimately, a fully integrated digital
breast imaging center will allow improved efficiency of
operation and enhanced imaging techniques. The rest of radiology
has moved to a digital environment, and we must as well.
Negotiating the jungle of electronic information in order to
achieve an integrated workflow and viewing environment is
a major challenge. The mammography and MR data sets are large. A
standard MR examination may provide >2500 images, and
transmission of these large data sets can be problematic.
Development of a single, integrated workstation, importing
disparate information from various modalities-mammography,
ultrasound, and MR-is a high priority. A multivendor, multimodality
viewing environment, with adequate monitor space, and a fully
integrated computer-aided multimodality detection and diagnostic
system will allow the breast radiologist to function
efficiently in the new digital environment. Let's hope
that we do not have to wait too long!
REFERENCES
- Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2006.CA
Cancer J Clin. 2006;56:106-130.
- U.S. Department of Health and Human Services, Centers for
Disease Control and Prevention, National Center for Health
Statistics. Health United States, 2005. Available at
http://www.cdc.gov/nchs/hus.htm. Accessed May 19, 2006.
- American Cancer Society. Breast Cancer Facts & Figures
2005-2006. Available online at: http://www.
cancer.org/docroot/MED/content/MED_2_1x_Breast_Cancer_Facts__Figures_2005-2006.asp.
Accessed May 19, 2006.
- Wing P.IOM Mammography Projects and Related Background
Information. Rensellaer, NY: State University of NY, School of
Public Health, Center for Health Workforce Studies. 2005.
- US Census Bureau. U.S. Interim Projections by Age, Sex, Race,
and Hispanic Origin. Available at
http://www.census.gov/prod/2004pubs/04statab/health.pdf. Accessed
May 19, 2006.
- Sunshine JH, Maynard CD, Paros J, Forman HP. Update on the
diagnostic radiologist shortage. AJR Am J Roentgenol.
2004;182:301-305.
- Enzmann DR, Anglada PM, Haviley C, Venta LA. Providing
professional mammography services: Financial analysis. Radiology.
2001;219:467-473.
- Newstead GM, Schmidt RA. Integration of Digital Mammography
into Clinical Practice: Initial Experience. Presented at the 6th
International Workshop on Digital Mammography. Bremen, Germany;
June 22-25, 2002.
Ms. Willison
is a Consultant,
Ms. LaBella
is the Lead Digital Technologist, and
Dr. Zuley
is a Staff Radiologist at The Elizabeth Wende Breast Clinic,
Rochester, NY. Ms. Willison is also the Director of Clinical
Affairs, Koning Corporation, Rochester, NY, and Dr. Zuley is the
Chair of the IHE Mammography Working Group.
Last year, approximately 150 certified U.S.
mammography facilities closed their doors. In April 2005, there
were 9011 such centers in operation; by April 2006, that number had
decreased to 8860.
1
At the same time, however, the number of full-field
digital mammography (FFDM) systems in use increased from 819 to
1331, and the number of facilities with at least one digital system
jumped from 607 to 924.
1
Whether the decrease in the number of mammography facilities is at
crisis level or not, digital technology has the potential to
increase access and exploit existing resources.
Benefits of digital mammography
One such efficiency found with digital mammography is
the ability to perform remote reading. With telemammography,
patients can be screened at one facility while the radiologist
reads the image at a centralized site without transporting physical
films. This means that one radiologist can service a
variety of screening locations, thereby providing increased access
without increasing the number of physicians.
In addition, digital mammography offers a variety of other
advantages. One is the immediacy of the process. The button is
pushed and the image appears. The image can then be reviewed for
quality control (QC) while the patient is still in the room, and
the image can be retaken, if necessary.
Another important advantage of digital mammography is its
capacity to more clearly image dense tissue (Figure 1). The Digital
Mammography Imaging Screening Trial from the American College of
Radiology Imaging Network illustrated the value of this
technology's increased contrast resolution to better detect cancers
in subgroups of women who predominantly have dense breasts.
2
With digital mammography, the image acquisition is separate from
display, leaving unlimited access to the original image. There also
might be a reduction in the need for retakes because of incorrect
technique with digital images. In the beginning, however, this may
not be the case, as the technologist progresses through the
learning curve on the digital system. Most importantly, however,
digital data finally provides the potential to truly step
into the next generation of breast imaging. Technologies that will
likely springboard from the digital platform are computer-aided
diagnosis (CAD) and 3-dimensional imaging techniques, including
tomographic imaging (such as tomosynthesis and computed tomography
[CT]), subtraction, and dual-energy techniques.
In theory, 1 digital system can replace 2 analog units, but in
order to achieve this goal, workflow and connectivity
must be streamlined. Seemingly simple tasks can take a long time to
resolve, and, in our experience, our digital units have not been as
reliable as our analog units. There are generally fewer steps for
the technologists, less wait time for the patient, and faster
throughput-as quick as 5 minutes of room time per study, without
associated out-of-room tasks, which is the primary difference
between analog and digital. Digital mammography is predicated on
the fact that the technologist stays in, or at least very near to,
the digital room. Efficiencies can best be realized with
this approach.
Digital mammography and the technologist
Switching from analog to digital technology can seem like a
daunting prospect for the technologist, but with a little patience,
the technologist will become just as expert with digital
mammography as with analog. It is not necessary to be computer
literate to perform digital mammography; applications training will
provide the necessary groundwork to use the equipment. New users
should remain open-minded and spend time with the system. If your
facility is switching to digital slowly, get in the digital room
and use the system. The learning curve also includes the
assimilation of proper terminology in order to converse in the
language of digital mammography. For example, the terms "too light"
and "too dark" are irrelevant terms, but "signal" and "noise" are
most appropriate for the digital technology.
The digital system
In many ways, digital mammography is very similar to analog. In
other ways it is quite different. Full-field digital
mammography (FFDM) systems are composed of 3 main components: the
acquisition stand or modality, the acquisition (or modality)
workstation, and the diagnostic workstation (Figure 2). The
modality or acquisition stand is very similar to that of an analog
mammography system, with the defining difference being
the detector. In a direct radiography (DR) FFDM system, a digital
detector replaces the slotted bucky/cassette holder. The U.S. Food
and Drug Administration (FDA) recently approved a computed
radiography (CR) mammography system that uses digital cassettes
that are similar to and replace the film cassettes. The
modality workstation typically consists of a 1- or 2-mega-pixel
(MP) monitor, a keyboard, and a computer. The technologist will
perform acquisition-related tasks at the modality workstation,
including setting technique, previewing images, and archiving or
printing images. The diagnostic workstation, where the radiologist
reads the image, consists of two 5-MP monitors for image review, a
keypad to navigate the system, and, usually, a third
nondiagnostic-grade monitor for workflow. When
first approved, the FFDM systems were accompanied by a
diagnostic workstation, but more recently, the FDA has separated
these components, leaving way for mammographic images to be read on
a picture archiving and communication system (PACS) workstation.
The PACS workstation, however, must be FDA-approved to display
mammographic images.
Using digital mammography systems
The specifics of general digital technology are beyond
the scope of this article; however, several very helpful articles
on this topic have been published.
3-5
In brief, with digital imaging, the X-ray beam or photon, now
referred to as
signal
, is converted to an electronic or digital signal. As in general
digital radiography, there are 2 types of digital mammography
technology: DR and CR. With DR, there is no cassette. The breast
support holds the digital receptor, and the image is captured
directly on the unit and is ready for immediate display at the
modality workstation.
In contrast, CR technology employs cassettes that are similar to
those used in analog units, although they contain an imaging plate
instead of film. Rather than taking film from
the cassette to be developed, a CR cassette is placed in a digital
reader and the image is displayed at a workstation (Figure 3). The
workstation could be located in the mammography room or may be
shared between up to 3 examination rooms.
Although digital image capture technology is
significantly different from screen-film
technology, the clinical technologist must still balance contrast
and spatial resolution with dose and must apply appropriate
techniques in order to obtain optimal image quality for
interpretation.
There are 2 aspects of mammography interpretation: detection and
characterization. The radiologist first must be able to
detect the lesion and then be able to characterize features in
order to determine whether or not to perform a biopsy. For the
technologist, it is important to learn how the digital system works
and, when there is access to more than one mammography system, to
know which system will provide the best image for the patient being
examined. Of course, technical application is greatly
influenced by the interpreting radiologist, and the
technologist should expect a learning curve for the radiologists as
they and you learn to work-up lesions with the new technology.
Processing
The hallmark of digital imaging is that image acquisition,
processing, and display are separated. When creating an image, the
digital system first produces a raw data set, and then
electronic processing is applied. The terminology for raw data is
"for processing" and the processed image is known as "for
presentation." With early digital mammography systems, the
acquisition stand provided the raw data and sent it to the
diagnostic workstation to be processed. In the newer FFDM systems,
the processing function has been moved to the acquisition
stand.
Processing algorithms, which are then applied to the "for
processing" data, optimize the presentation state of the image.
While processing improves the display and makes the image more
pleasing to the eye, processing cannot add information to the
image. Currently, each FFDM vendor has its own proprietary
algorithm, all of which are continuing to evolve. This will be the
status quo for a few years, but in my opinion, we may be moving
toward a system that employs processing boxes to which all raw data
will be sent, regardless of origin, and all images will be
processed in a consistent manner that will likely be chosen by the
primary interpreting radiologist(s).
Image acquisition and display
Digital detector
It is important to understand the origin of the digital image in
order to properly apply technical factors. A digital acquisition
platform is made up of small elements called pixels (or detector
elements), which are arranged in a square or rectangular shape
(Figure 4) referred to as a matrix. The space between the pixels is
known as the pixel pitch. The size, pixel pitch, and arrangement of
the pixels in the matrix provide for the spatial resolution of a
system. Pixels also have bit depth (think of them as "wells" that
fill up with X-ray photons). The bit depth of the pixel
determines the number of shades of gray, which, in turn, provides
the level of contrast resolution or-in digital speak-dynamic range.
These factors are the essence of a digital receptor and, just like
a screen-film combination, have characteristics that are
unique to each detector. The FFDM systems in use today have
detectors with pixel sizes ranging from 25 µm to 100 µm. As pixel
size decreases, spatial resolution increases, but so do noise,
radiation dose, and storage requirements.
Looking at different matrices (Figure 5), one can see that,
given the same bit depth, as the pixels get smaller and the number
increases, the amount of information also increases. It is
important to reiterate that as pixel size decreases, resolution
will increase, but so will the noise and the dose factor.
Manufacturers have carefully balanced pixel size and matrix in
consideration of these factors.
Technical applications
Digital mammography has a new set of parameters for technical
application. The technologist will no longer think in terms of
mAs
and
kVp
but in terms of
signal
and
noise
and the ratio between the two. Signal is the X-ray photons coming
out of the tube. Noise is anything that interferes with the
visibility of useful signal and includes quantum noise or mottle as
well as electronic noise, a constant presence in digital receptors.
Detective quantum efficiency (DQE), which is expressed as
a percentage, is the ability of a system to detect and use exiting
X-ray photons (the signal). In theory, the greater the DQE, the
less signal (dose) is needed.
The goal of technical application is to achieve adequate signal
to fill the pixels and overcome existing electronic
noise, without overfilling. While the beauty of a digital
image is that display is separate from acquisition, this also adds
difficulty in evaluating the quality of an image, as at
first glance, a digital image will always look "good."
Under- and overexposure will not result in a "dark" or "light"
image, but may result in a noisier image in the case of
underexposure or poor contrast in the case of overexposure. Figure
6A shows an overexposed image, and Figure 6B shows the same image
at the correct exposure; notice how flat in contrast the
overexposed image appears. This will not be able to be made better
with windows and leveling. Note how more calcifications
are apparent in the correctly exposed image. Note also the increase
in noise in the "correctly" exposed image.
The technologist will adjust mAs and kVp as a means to achieve
adequate signal-to-noise ratio. Kilovoltage no longer has a great
effect on image contrast but rather will be used to boost signal
because image contrast is largely dependent on the dynamic range of
the digital detector and the digital imaging chain. With digital
technology, adequate exposure is measured with analog-to-digital
units (ADUs) or exposure index (EI). Ranges for adequate exposure
are provided by each manufacturer, and digital automatic exposure
controls (AECs) allow for excellent exposure control. The
technologist should understand that the entire detector or imaging
plate is used for exposure control, in contrast to analog imaging,
in which just a small, usually central phototiming detector was
employed.
Patient positioning
The primary difference between FFDM and analog positioning is
that the technologist has only one surface on which to position all
breast and patient sizes. In addition, the digital detector is
thicker, which means it is a little more difficult to
accommodate a large abdomen and other more difficult body
habitus. A positive aspect of the DR detectors is that the entire
image receptor area acts as a digital AEC, which means that the
breast does not have to be centered over a photocell. This allows a
smaller breast to be positioned higher up on the image receptor for
adequate positioning.
Image display options
Once the image is acquired and processed, it is typically
displayed on monitors (however, in some situations, digital images
may be printed to film for interpretation). Typically,
the data is acquired at an acquisition matrix size of approximately
20,000,000 pixels in roughly a 10 × 12-inch matrix. The display
(monitor) technology displays only 1 to 5 million pixels. What this
means is that an entire image cannot be fully displayed on one
monitor at full resolution. For this reason, soft copy workstations
provide 3 ways for the images to be displayed. One option is called
"fit to screen," in which the information is downsized to
fit to any window in which it is displayed. A second
option is "true size," which displays the image using the true size
of the breast. Both options do not display the full data set of the
digital image. A "pixel-to-pixel" or full-resolution display is the
only display option that provides the entire data set. One issue
that still needs to be addressed by FFDM manufacturers is the
display monitor at the acquisition workstation. The acquisition
workstation monitors are approximately 25 inches on the diagonal,
with just 1 to 2 million pixels. This makes it more
difficult for the technologist who must display the image
in pixel-to-pixel mode and spend time panning the image to detect
motion.
Quality control
Detecting motion
At our facility, the technologists reported that it was
difficult to detect motion on the 2-MP QC monitors in the
imaging room. When we looked carefully at this issue, we found that
the problem wasn't in detecting motion, but more in
confirming that there was no motion. On the 2-MP
monitors, many images look somewhat fuzzy, although they appear
smooth on the radiologists' 5-MP monitor. One way to address this
is to display the image using pixel-to-pixel resolution and check
for gross motion.
Artifacts
As with analog imaging, artifacts can occur with digital
mammography. Digital mammography artifacts are not yet widely
understood and can be a time-consuming problem to resolve. Some
artifacts may be very subtle, but they can have a dramatic effect.
Artifacts arise from the detector, processing, and the monitor as
well as the X-ray tube, filter, and grid.
The radiologist has a higher-resolution monitor and may see
artifacts more readily than the technologist. Monitor artifacts can
be particularly difficult because the technologists and
the radiologists are viewing the image on different monitors.
Therefore, an artifact on the radiologists' 5-MP monitor will not
appear on the 2-MP monitor that the technologist used to perform
the QC.
DR FFDM systems directly convert X-ray to digital signal. Such
units may exhibit trouble in completely clearing the imaging
detector of the previous image or images, which can result in
"ghosting" artifacts (Figure 7). It is not clear at what level
ghosting noise interferes with the diagnostic quality of an image,
if at all. The image displayed in Figure 7 was acquired using the
QC flat-field phantom. Outlines of previous
mammogram images are visible as a ghosting artifact. The ghosting
may get worse with detector age, as was the case with this early
version of a DR detector, which had to be replaced.
Quality assurance
Quality assurance measures for digital mammography are still
evolving. Currently, system testing is conducted using
manufacturing paradigms that are ap-proved by the Mammography
Quality Standards Act (MQSA) for each individual vendor's system,
but the American College of Radiology (ACR) is working on
developing a uniform set of standard tests for all systems. All
parts of the digital unit must undergo quality assurance, including
the diagnostic workstation, the acquisition workstation, the
acquisition stand, and the printer.
System servicing
Servicing of FFDM systems is vastly different from that of
analog systems, and this has both advantages and disadvantages.
Some servicing issues can be worked out over the phone, thereby
eliminating downtime while awaiting the arrival of a service
technician. The downside to this is that the technologist, in
effect, becomes the service person, often working in tandem with a
technician on the phone. Therefore, it is very important to have a
phone, preferably a cordless one or one with a very long cord, in
the digital room.
Another advantage to servicing an FFDM system is the ability to
conduct remote dial-in servicing. This means that the servicing
company can sometimes diagnose and rectify a problem remotely
through a modem or virtual private network.
Field service engineers and technologists are on a learning
curve for troubleshooting, and the technologist and service person
may need to work together to determine the cause of a problem.
Historically, service engineers have been mechanically oriented.
Now, with the new technology, they must be more computer savvy. If
you have the first digital system in your area, it's
likely that you're going to be on the learning curve for that
service engineer.
Servicing and performing quality assurance testing of FFDM
systems may also be a matter of geography. The diagnostic
workstation will be remote to the acquisition stand, and a printer
may be in a third location, yet all of these components must be
tested, maintained, and documented according to MQSA standards.
Conclusion
The promise of digital mammography lies not in the use of the
abundant data set to produce a 2-dimensional image, but in the
ability of FFDM to take us to the next generation of breast
imaging, including tomosynthesis, CT mammography, contrast-enhanced
subtraction mammography, CAD, and, eventually, less invasive
methods of biopsy and treatment of breast cancer, blurring the
lines between diagnosis and treatment.
For the technologist, however, although the tools may change,
their primary job is that of listening to and forming a
relationship with the patient, in order to provide the best images
and pertinent information for interpretation. That does not, and
will not, change with digital mammography or any other new
technology.
REFERENCES
- United States Food and Drug Administration Center for Devices
and Radiological Health. Mammography: MQSA Facility Score Card.
Available online at:
http://www.fda.gov/CDRH/MAM-MOGRAPHY/scorecard-statistics.html.
Accessed April 15, 2006.
- Pisano ED, Gatsonis C, Hendrick E, et al. Diagnostic
performance of digital versus filn mammography for
breast-cancer screening.N Engl J Med. 2005;353: 1773-1783;
comments in: N Engl J Med. 2005;353: 1846-1847 and N Engl J Med.
2006;354:765-767; author reply: 765-767.
- Balter S. Fundamental properties of digital
images.RadioGraphics. 1993; 13:129-141.
- Pisano ED, Cole EB, Hemminger BM, et al. Image processing
algorithms for digital mammography: A pictorial essay.
RadioGraphics. 2000;20: 1479-1491.
- Pisano ED, Yaffe MJ. Digital mammography. Radiology.
2005;234:353-362.
Dr. Schmidt
is a Professor of Radiology and the Director of Breast Imaging
Research, Department of Radiology, University of Chicago,
IL.
The author reports relationships with FUJIFILM Medical
Systems USA, Inc.; R2 Technology, Inc.; Philips Medical Systems;
and Konica Minolta.
In girum imus nocte, et consumimur igni.
The Divine Comedy, Dante Alighieri
In Dante's
The Divine Comedy
, the Devil replies with this palindrome when asked what goes on in
Hell. It translates as, "At night we go down into the circle pit
and we are consumed with fire." For radiologists today,
work can be a bit like that: it can be difficult, at
times, and you have to be prepared to get a little burnt. When I
was a youngster,
Ripley's Believe It Or Not!
listed this as the world's longest palindrome (reads the same
forwards and backwards). How times have changed. With the advent of
computers, palindromists can claim record lengths of 64,000
letters, or 2000 times longer than Dante's, although his makes
elegantly much more sense than the modern creations. Therein lies
the rub. When Hell was an analog destination, we all learned Latin
in high school and were taught to be erudite. Now we face the new
torture (perhaps it should be "taught-u-are") of all things
digital. Does it really make our lives better or worse? Does it
really make more sense?
Digital technology in breast imaging is changing the demands
that a picture archiving and communication system (PACS) must meet
in terms of storage, display technology, transmission speed, and
network compatibilities. With digital mammograms that started at 9
megabytes (MB) per image and are now reaching 140 MB per image
(roughly equivalent to the 15 to 20 line pairs (lp)/mm resolution
of conventional screen-film mammography), breast magnetic
resonance (MR) studies that have >3000 images, and whole-breast
ultrasound volumetric renderings that are >100 MB, the future is
not what we used to think it was, to paraphrase Yogi Berra. To
date, <10% of the Mammography Quality Standards Act
(MQSA)-registered mammography units are digital. But soon, the
digital monsoon will be upon us, and the information technology
dikes were not built to handle this category of data. Expect more
change, and your expectations will be satisfied. The DEC
PDP-8 computer I used for my master's thesis 30 years ago had only
16 kilobytes (Kb) of random access memory (RAM). Following Moore's
Law, the laptop computers we now use for presentations can have
>100,000 times that in RAM, making the advances in palindromy
somewhat less surprising.
Digital mammography
Digital images are very data-intensive. A single 18 × 24-cm
breast image acquired on a full-field digital mammography
(FFDM) system with a 50-µm detector will contain approximately 35
MB of data. Systems with smaller pixel-size detectors produce
significantly more data (Table 1). Multiply that by 4 or
6 or more images per study and by 10,000 studies per year, and you
are left with a large amount of data (several terabytes [TB] ) that
must be networked, stored, easily accessed, and optimally viewed.
There are certainly practices that read ≥50,000 mammography studies
per year. How many years of comparison studies do we need? Five?
Ten? This means that we may all need to start learning about a new
unit of data: the petabyte (10
15
). I studied Greek as well as Latin, but I had to use Google to
find out what that level of storage would be called. One
of the issues that radiologists face is that many of the tools we
use are relatively primitive when it comes to dealing with such
large amounts of data. Currently, state-of-the-art diagnostic
display monitors, for example, display 5 megapixels (MP) of data.
When looking at a standard 4-view display of such mammographic
images on a 5-MP monitor, the radiologist is seeing only 1/16 of
the information. In the near future, images may be available that
contain 140 MB of data each. How will clinicians view these?
The current trend is to make digital resolution as close to
film as possible. While contrast resolution has been the
strong point of digital mammography, there have been doubts about
giving up the previously unrivaled high spatial resolution of
analog mammography, with its depiction of fine
calcifications and thin spiculations that allow us to
find and diagnose breast cancers. So improved digital
resolution will continue to be a part of the digital revolution, in
much the same way as we are seeing this in the quest to change a
century-and-a-half of photographic imaging, with digital
single-lens reflex cameras that now can have up to 17-MP
image receptors and 8-gigabyte (GB) compact flash
storage. The question is, however, whether we as radiologists are
truly satisfied with the resolution of film
mammography. When viewing microcalcifications on a
mammogram, the radiologist is actually seeing an aggregate
50-to-several-hundred µm in size, not the individual
microcalcifications, because both analog and current
digital systems are inadequate to clearly image objects this
small.
I once conducted a small study in which I asked the pathologist
to measure the actual calcifications that were reported.
Generally speaking, the benign calcifications were
roughly 10 µm in size. The malignant calcifications were
approximately 100 µm to 500 µm. Clinical phantom testing done as a
part of the Illinois Radiological Society mammography accreditation
program in the late 1980s, (which was an important precursor of the
American College of Radiology Mammography Accreditation Program)
showed that it is virtually impossible to routinely see less than a
100-µm calcification on screen-film
mammography. This means that there are going to be
calcifications that are not visible on analog
mammography. With improved technology, however, we may one day be
able to image even the tiniest calcifications and,
thereby, improve our diagnoses and detect earlier cancers.
Networking and standards
Digital Imaging and Communications in Medicine (DICOM) standards
are used in all facets of radiology today. The specific
standards for digital mammography, however, are still evolving.
Many equipment manufacturers still use proprietary
subfields that make it difficult to transmit
images across varying systems. Eventually, all manufacturers will
need to em-brace a single standard so that all images will be
viewable on all workstations and so that all processing and
manipulation of the images can be performed in the same manner
regardless of the manufacturer. Since different image-processing
algorithms are now evolving, the question of whether raw image data
storage should routinely be done is raised. Processed image
storage, which is what is most frequently done now, may cause
problems in the future when algorithms and display methods change,
if the new methods cannot be used to make the older images similar
in appearance for comparison purposes. As I point out time and
again in my mammography reports when I have inadequate (or no)
comparison films, mammography works best by looking for
changes. So our sensitivity is dependent on our ability to tell
whether a change in appearance is due to a change in processing for
presentation or to a real change in the tissues. If you haven't yet
done this, compare several currently available systems; the
differences can be surprising. Mammograms obtained on digital
systems from Hologic, Inc. (Bedford, MA), Fischer Imaging
Corporation (Northglenn, CO), and GE Healthcare (Chalfont St.
Giles, UK) all have distinctly different "looks" that can sometimes
confuse even an experienced observer when direct comparisons are
made.
Another standard that needs to be developed is one that will
allow the user to annotate images. With film, notes can
be written directly on the image using a crayon. How do we do this
with digital images? Manufacturers need to develop conventions for
annotations. Again, this must be standardized. Will the annotations
be permanent or erasable? Who will have the ability to annotate
images: the technologists, the radiologist, the clinician, the
paralegal in the plaintiff's law firm? All of these
issues must be addressed.
Data storage
Physical storage of films used to be a problem. This
is one of the areas in which digital technology has greatly
improved the process. As noted above, if you have roughly 35 MB of
data per image (small image receptor, 50-µm pixels) and you acquire
6 images per patient, and you have 10,000 patients, you will need
2.1 TB of storage per year, or, over a 10-year period,
approximately 20 TB of storage. Larger patient volumes at some
institutions could push that requirement upwards of ≥100 TB.
Fortunately, the cost of electronic storage has been dropping
rapidly as technology improves, so cost is generally not the most
significant issue. But the speed of retrieval is.
There are other storage issues that need to be addressed,
however. Images acquired using larger field sizes or
higher resolution detectors produce more data, and, therefore, the
storage requirements increase. Saving both the raw and processed
data will nearly double the amount of storage needed.
These storage requirements can be somewhat decreased by data
compression. There are several options for compression, including
lossless and lossy compression from which facilities can choose.
While this is not my area of expertise, I believe
significant decreases in data storage requirements are
likely to be achieved for processed images, as has been shown for
chest imaging. But that specific research is still in
progress for the detail-dependent modality of mammography. Since
the future is not yet here though, what if computer-aided detection
(CAD) temporal subtraction techniques evolve that work best on
uncompressed raw data? Academic institutions may be more inclined
to hedge their bets in this area, and opt for storing the raw
data.
Local image storage is another concern that must be addressed.
Many workstations hold very little data, usually 60 to 80 GB-less
hard drive storage than is common on today's laptops (the portable
computer I am writing this on has 100 GB storage, and my desktop
Macintosh G5 has 500 GB). In most facilities, this is only
approximately 1 month's worth of images. Therefore, the retrieval
of images for patients who were last imaged >1 month earlier may
be delayed while the images are retrieved from the PACS,
particularly if this is a manual push initiated by the technologist
or the time-frustrated radiologist in a diagnostic mammography
setting. Increased short-term storage capabilities could greatly
increase clinical efficiency. As we get more digital
workstations in mammography, it will become increasingly important
to have scheduled patients' previous images (which eventually will
be multiple examinations over years) prefetched by PACS worklists
to the correct workstation.
Image movement
Image movement is still an issue with digital mammography. With
early digital mammography systems, the acquisition workstation was
connected directly to the review workstation and all images were
contained within the local system. This meant that all image
reading had to be conducted on the system's dedicated workstation.
This is not efficient. We must have vendor-neutral,
multimodality workstations so that all images can be viewed on all
workstations regardless of the manufacturer.It is very
difficult to share a workstation when reading imaging
studies, and, therefore, it is best to have 1 review station for
each full-time equivalent radiologist working each day.
In addition, images should be sent through a quality control
workstation before the data are entered into the PACS. Because the
patient data is burned into the examination, it is essential that
the information be correct. My personal record in the analog era at
the University of Chicago is one 4-view study with 3 different
patient names on it, but I suspect that there probably is a record
of 4 names on the 4 views somewhere. The bottom line is, however,
that once an error is entered into the digital data and the data is
sent to the PACS, there is virtually no way to retrieve the images
again. Most current systems do not allow users to easily change the
patient's name or other data, and, unlike film, you
cannot just put a sticker on an electronic image. This is another
area for which standards must be developed.
Retrieval speed can be an issue for digital mammography
workflow as well, depending on the background network
being used. As we have seen, as the image volume in breast MR
imaging has increased, the switch capacity, network node
distribution, and PACS priority categorization of different image
modalities can all affect our ability to view the images in a
timely fashion.
Auto-push to the PACS is desirable to make images widely
available after acquisition and to ensure their storage, but even
more desirable is auto-pull from the daily worklist. With a
worklist-driven PACS, auto-pull can greatly improve
workflow. Inputting the patient information by hand in
order to locate studies can be very time-consuming. Also, if images
are sent directly from the acquisition workstation to the review
workstation and old images have not been retrieved from the PACS to
the review workstation before the new images arrive, the
workstation may not recognize this as the same patient, resulting
in different examinations for 1 patient appearing twice on the
worklist, as if they were 2 different patients. This makes
comparison very difficult on our current workstation, and
this was not a rare occurrence before we worked to correct it.
Right now, each of the digital mammography systems available in
the United States uses different detector technology and different
processing. We have already seen one of these systems pass into
what is essentially obsolescence: the Fischer SenoScan will no
longer be manufactured after acquisition of the intellectual
property rights by Hologic earlier this year. This situation is not
likely to be unique and emphasizes that flexibility in
image retrieval and display is important, as the proprietary
Fischer workstation that is part of our unit does not allow
viewing, for example, of GE images. So it clearly has a limited
lifetime now that this is a "legacy product."
In the earlier phases of digital mammography development,
sticking with one manufacturer could shield you a bit from some of
these soft-copy incompatibility concerns, but as digital
mammography increases over the next few years, it is clear,
certainly at a tertiary referral hospital like mine, that we will
have to be able to view images from other institutions that have
made different equipment purchase decisions. So, the era of the
proprietary workstations is appropriately ending, and these will
soon be obsolete. The proliferation of ancillary workstations to do
certain image processing and CAD is also an area that has not yet
been clarified. Software from third-party sources and
integration of all the modalities that are important to breast
imaging will have to be more accessible on the primary workstations
of the future, if we are not to drown in too many monitors.
Putting it all together
Who is really responsible for making this system as
efficient as possible? Some may say it is the digital
mammography vendor's problem. Others say it is the PACS provider's
responsibility. Still others say it is the workstation
manufacturer's problem. But the truth is, as the radiologist, it is
your problem. Therefore, when purchasing equipment, it is
imperative that clear performance standards be set with the vendor.
Clearly state in all contracts that systems to be purchased must
work within certain specifications in your information
technology (IT)/PACS environment or they will be removed. When
shopping for a new system, ask to be shown another facility where
the system is in use or ask for some form of performance guarantee.
Pretend to be from Missouri, the "Show me" state.
Problem solving
At the University of Chicago, we have been using digital
mammography in conjunction with our PACS since 2002, during which
time the PACS has changed once. Neither PACS has been intrinsically
friendly to digital mammography, as the PACS vendors have not yet
had significant demands for this type of product. During
this time, several issues have arisen that we have tried to
address. One issue was the time-consuming problem of having to
manually push or pull the digital mammograms to and from the PACS.
I thought we would be able to eliminate this issue with the
installation of our new PACS (since it was supposed to automate
these functions), but as I write this, it has become an
increasingly time-consuming task for the technologists to continue
to do this manually. For a low-volume, single-site operation, this
may not be a problem, but for our facility this is still a thorn in
our digital sides that needs removal.
Another problem was that the digital mammograms acquired on one
system could not be viewed on a different vendor's workstation.
This is in the process of being fixed by the purchase of
a multivendor, multimodality workstation, but this type of
workstation is still in its developmental stages. We also became
aware that we were unable to use the Premium View features (GE
Healthcare, Chalfont St. Giles, UK) on stored processed images. In
order to overcome this particular limitation, we wanted to begin
saving the raw data as well as the processed images, but this has
left us stuck between our IT team and several vendors, and this
also remains unresolved.
We had difficulty retrieving old digital images for
comparison with our first PACS. At first, we
printed all images, but now the technologists push the images to
the review workstation each day. This is not a 100% fix,
however. Auto-pull would be a significantly better
solution.
We also found that our CAD data was not being displayed on one
particular vendor's system, although the CAD vendor was providing
compatible output. After an extended attempt by the local IT team
to solve this problem, the FFDM vendor was called and was able to
quickly fix the problem. When it comes to troubleshooting
and servicing, it is necessary to be persistent and willing to try
alternate pathways. We also found that CAD marks could not be
stored in the PACS for our digital images, and neither the
digitized analog images nor the CAD marks for them could be stored.
As a temporizing measure, we now use an inexpensive thermal paper
hard-copy print that works very nicely, and this stores CAD marks
in the patient's jacket, just as we used to do with everything
before we went digital. This provides a permanent record and has
been extremely beneficial many times when the electronic
display is incorrect (when displayed patient information is missing
or wrong, when there are system electronic display problems, etc.).
While there is debate about whether CAD marks should be stored, my
strong advice is to do so, as they are really part of the patient's
medical record. They can vary when analog images are redigitized or
algorithms improve, and they are what you used to make your
decision. But this is not the digital future. So we have now
ordered software that will allow us to store the digitized images.
But we are still having a problem with the overlays in the PACS for
the digitally acquired mammograms, and we continue to print those
results. Time will heal this too.
Breast imaging is no longer limited to mammography, and
workstations of the future must accommodate multimodality reading.
Currently, MR image viewing is limited to several dedicated MR
workstations at our facility. We can review MR on the PACS, but we
cannot do simultaneous multiplanar (axial, sagittal, and coronal)
review, or get maximum intensity projections or gadolinium-uptake
curves. To see these views, we have to use a special workstation or
purchase special integrated software. Even with third-party
software that solves some of these problems, we all prefer to use
the dedicated MR workstation for the multiplanar review software
that is not available on the PACS. In addition, MR images can be
slow to arrive at the review workstation. In my experience with a
new magnet and breast coil, they have taken up to 18 minutes just
to load, not including the time spent reading the images. This is a
PACS network problem, but it has been nettlesome to eliminate it.
One way to make this process more efficient is to send
the images directly to the workstation (direct wiring) as well as
to the PACS simultaneously.
Other improvements that I would like to see in diagnostic
workstations include larger viewing areas, improved resolution, the
flexibility of black-and-white or color image display,
voice-activated commands, and more local storage capabilities. I
would also like to see the development of software designed to
guide presentation, which could reside on the workstation itself.
In other words, we need to develop viewing protocols as well as
hanging protocols. Remember that for 50-µm digital mammography
images, the current standard of 5-MP monitors displays only one
quarter of the information, averaged to fit to the
monitor, even when you look at only 1 image view per monitor. If
you have 2 views per monitor or include comparisons on the same
monitor, the displayed information content is averaged accordingly
and is even less. So if you prefer to see each breast quadrant at
full resolution and presented in a certain order, this could be
preset at your preferred pace in the digital future. Additional
automations, such as display sequences of the system, and increased
CAD-like capabilities, such as progressive masking, would also be
beneficial.
Conclusion
Digital mammography and the increased use of other digital
breast imaging modalities promise to radically alter the way we
practice. More research-stage advances, such as digital
tomosynthesis and whole-breast ultrasound, hold promise for putting
all the modalities that we use into 3D, which is highly desirable.
To say that we have achieved great progress is true, but the
challenge of implementing this progress in routine clinical
practice remains, and it is likely that the pace of change will
continue for some years to come. Imaging continues to increase in
importance in finding, diagnosing, and monitoring
treatment of breast cancer. Our medical colleagues have become
increasingly dependent on our ability as radiologists to provide
this information in digestible form both accurately and rapidly.
The volumes of information to be digested keep increasing, leading
to the sorts of hiccups along the way to the digital future that I
have described above. But you cannot just hold your breath in the
hope that they will go away. To get to that future requires
planning, patience, and the increased insistence that vendors help
us address these issues on the path of continuous quality
improvement.
In the decidedly analog Hell of Dante, he would have had to
struggle to come up with a Latin phrase to describe our current
state of information technology (maybe just the Latin "id" for "IT"
would do) as the premise that promises to either free or totally
consume the world. But being a devil is a fairly mundane and
predestined job, with little hope for advancement. Putting on our
collective thinking caps and rolling up our sleeves can get us out
of the pit, off the pyre, and into the promised land heralded by
the digital enthusiasts. And we must get there. It is really our
only salvation.
Dr. Newstead
is a Professor of Radiology and the Clinical Director of Breast
Imaging, the University of Chicago, Chicago, IL.
Breast imaging has advanced significantly since the
time when film-based mammography was the only imaging
tool available for breast cancer diagnosis. Today, multimodality
screening and diagnosis employing analog and digital mammography,
ultrasound, and magnetic resonance (MR) imaging of the breast is a
clinical reality.
Breast cancer screening
Mammography
It is currently recommended that all women begin getting annual
mammograms at the age of 40. Testing should begin sooner if the
patient is at increased risk for breast cancer through a family
history of premenopausal cancer, genetic disposition or through
prior chest irradiation (eg, treatment for Hodgkins disease).
Such high-risk patients should be referred to a high-risk
assessment clinic that can provide the patient with all the
necessary information and make a judgment as to whether or not
additional screening methods, such as whole-breast ultrasound or
screening MR, might be appropriate.
Both analog and digital mammography screening have been found to
be effective in detecting cancer, but this effectiveness can be
limited by a variety of factors, including patient age and breast
density. One recent study found that mammography has a sensitivity
of 87.0% for detecting lesions in fatty breasts but that that
number dropped to 62.9% in dense breasts (Table 1).
1
Other factors, such as image quality and the experience and
training of the interpreting radiologist, also play a role.
Ultrasound screening
According to general estimates, there are approximately 70
million U.S. women eligible for mammography today, 40 million of
whom undergo mammography screening. Of those screened women, 90%
are told they are healthy based on the mammographic study, but a
small percentage -roughly 40,000-will actually have cancers that
were missed at mammography. Ultrasound screening may be
beneficial in detecting some of these mammographically
occult cancers. Although there is no randomized controlled trial
data to support the efficacy of ultrasound screening, the
next American College of Radiology Imaging Network trial results
(ACRIN 6666) should provide important additional information.
Screening MR
The detection rate of screening MR is significantly
higher than that of ultrasound; however, the high cost per patient
of MR is a concern. MR screening should be reserved for only those
women who are at extremely high risk for breast cancer, such as
those who are genetically predisposed or have at least a 20% to 25%
lifetime risk of developing breast cancer. Women who carry the BRCA
1 or 2 gene have up to an 85% lifetime risk of developing breast
cancer. These women also tend to have an earlier onset of disease
and a higher prevalence for bilateral disease. These are the types
of patients who should be considered candidates for MR breast
cancer screening and should be evaluated in a high-risk- assessment
clinic.
Despite the high per-study cost of MR, if this screening method
is reserved for only extremely high-risk women, its high yield will
result in a cost per cancer found that is similar to the cost of
finding a cancer in an average-risk woman with
mammography. The yield is so much greater in the subset of patients
who are at very high risk that the cost is about the same.
When developing an MR screening program, it is important that
the MR screening population be clearly defined. Once
defined, it is important to monitor the program's
protocol to ensure that the guidelines are followed and that only
the designated patients are included. Also, it is important to
remember that the lesions that are found only with MR are most
likely to be occult mammographically and ultrasonographically.
Therefore, should a biopsy be required, it will need to be
performed with MR guidance.
A recent study compared the sensitivity and
specificity of clinical breast examination (CBE), MR
imaging, and mammography for invasive tumor detection in women at
high risk for breast cancer (Table 2).
2
Over 4 years, nearly 2000 women were screened, 358 of whom had
germ-line mutations. The participants underwent CBE every 6 months
and mammography and MR breast examination annually. With a median
follow-up of 2.9 years, 45 breast cancers were found: 39 invasive
cancers and 6 cases of ductal carcinoma in situ (DCIS). The overall
detection rate was 9.5 per 1000 for all participants and 26.5 per
1000 in those with the genetic mutation. The sensitivity for CBE
was found to be 18% (98% specificity), for mammography it
was 33% (95% specificity), and for MR imaging it was 80%
(90% specificity). The authors also found that patients
who carried the gene mutation also tended to have larger lesions
upon detection. In this study, 43% of the patients in the MR
surveillance group had lesions <10 mm, compared with only 12% or
14% of those in the 2 control groups. In addition, women screened
with MR were less likely to have positive lymph nodes at diagnosis.
In subsequent rounds, the more favorable prognosis for cancers
detected in the group that was screened with MR was maintained.
3
Breast MR imaging
How does MR imaging of the breast compare with mammography? With
mammography screening, typically only 2 views of the breast are
obtained. With the dynamic capabilities of MR imaging, the
radiologist can see throughout the entire breast in a range of
projections. Unlike X-ray technology, MR works well in women with
dense breast tissue, in women with scar tissue from prior surgery,
and in women with breast implants. With current MR imaging
techniques, the calcifications commonly associated with
non-invasive breast cancer (DCIS) are typically not seen. Rather,
the radiologist looks for the angiogenic effect of the lesion. In
addition, unlike mammographic examinations, MR imaging requires
contrast in- jection and a longer examination time.
The important advantage of a dynamic contrast-enhanced MR is
that virtually all cancers enhance following contrast injection.
This means that nearly all cancers will be visible on MR. MR
imaging also has a very high negative predictability for invasive
cancer. Therefore, if a patient with a suspicious clinical or other
imaging finding has a negative breast MR
finding with no enhancement, it is very unlikely that the
patient has an invasive breast cancer. This can be particularly
important among patients whose imaging may be complex because of
prior treatment or surgery.
Tumor angiogenesis makes cancer highly visible on
contrast-enhanced MR. The newly formed vessels tend be of poor
quality and leak contrast around the tumor. With gadolinium
injection, the alterations in the vasculature associated with
cancer are clearly visible, often making it easy to distinguish
malignant tumors from benign findings if the contrast
study is performed properly. The degree of enhancement will depend
on the histology of the underlying lesion, which also helps
distinguish malignant lesions from benign ones.
MR scanners
For MR imaging of the breast, a dedicated breast coil is needed.
The patient lies prone, and the breasts are suspended in the wells
and immobilized slightly to avoid motion. Markers are placed on the
nipples and any areas with scars, similar to what is done for
mammography. Early breast coils had only 2 or 4 channels. Current
systems have 7- and 8-channel coils, and some manufacturers are
currently developing 13- to 16-channel coils. The advent of
parallel imaging technology has dramatically improved image quality
when used with multichannel breast coils.
The challenges in breast MR include the issues of spatial and
temporal resolution. Spatial resolution is essential in order to
assess the morphology of lesions. All breast specialists are
familiar with the process of assessing morphology on mammography
and ultrasound. Translating those skills to MR imaging is very
straightforward. With MR, however, the issue of temporal resolution
is added. Good temporal resolution is needed to determine the
kinetic functions of lesions. Uniform fat suppression to enhance
conspicuity is also important. The 3-dimensional (3D) imaging
capability, the fourth dimension of temporal resolution, and the
exquisite soft tissue contrast that are possible with new MR
technique, provide vast improvements in image quality.
Temporal resolution allows radiologists to assess how quickly a
lesion takes up contrast. In the initial phase of the examination,
contrast wash-in is assessed. In the later phase, wash-out is
assessed. Benign lesions tend to enhance slowly and exhibit little
wash-out, while malignant lesions tend to enhance and wash out
quickly. Many radiologists believe the first images
should be obtained within the first 1 to 2 minutes
following contrast injection. My personal opinion is that the
closer to 1 minute, the better. The optimal time may vary somewhat,
depending on the magnet as well as the software and hardware being
used.
In our practice, the most common indication for breast MR is
evaluation of an index cancer or the presence of a highly
suspicious lesion pre-biopsy. Approximately 20% of our patients who
undergo screening MR do so because they are found to be at super
high risk for breast cancer or because they are extremely concerned
and their physicians ordered a screening MR. The remaining patients
tend to be previously treated cancer patients who undergo breast MR
for assessment of residual cancer questions, posttreatment
recurrence, or any of a variety of problem-solving issues.
Can breast MR improve the assessment of tumor size, margins,
numbers, and locations of cancers in patients with newly diagnosed
breast cancer? The answer to that question is unequivocally yes. We
find additional cancers in our practice up to 30% of the
time. Most of the lesions are in the same quadrant, but some are in
different quadrants or even in the other breast. The MR
findings alter therapy for roughly 25% of our patients
overall.
The big question is whether breast MRI affects survival. Are
these cancers that we are finding actually going to be
clinically important? I think the answer is yes. Many of these
findings are additional invasive cancers in either the
ipsilateral or contralateral breast that, if not diagnosed and
treated appropriately, will present as either a recurrent tumor or
a new tumor at a later date.
MR and DCIS
Initially it was thought that MR was not very useful in
detecting DCIS. This may have been a consequence of the fact that
DCIS manifests differently on MR than it does on mammography. On
MR, DCIS typically presents as a nonmass enhancement (Figure 1)
rather than as the calcifications commonly seen on a
mammogram. The angiogenic effects of DCIS are generally visible on
MR. Segmental nonmass enhancement, enhancement of the ducts, and
linear enhancement are commonly seen. In some cases, DCIS can
present as a mass, but this is less common. In our practice, we
often find noncalcified, mammographically
occult DCIS using MR.
With DCIS, it is often difficult to accurately size
the cancer; therefore, surgeons like to take wider margins when
employing breast-conserving therapy. With MR, when we
find noncalcified DCIS, we have to determine
how we are going to localize it for the surgeon. Often, we re-image
the patient and take magnification views with
mammography, to see if we can retrospectively find the
lesion, and at times we cannot. Therefore, in order to excise the
lesion, we must do a segmental excision using a bracketed MR-guided
needle localization procedure.
MR is also useful for assessing extramammary nodal disease and
for checking for tumor invasion into the chest wall. Because of the
3D format of MR, the posterior tissues can be clearly visualized
and it is possible to determine if a posterior lesion has invaded
the pectoral muscle. If enhancement of the pectoral muscle is seen,
chest wall invasion is likely. It is also possible to visualize
axillary lymph nodes with MR to determine if they are
morphologically abnormal. In the future, lymphotropic nanoparticle
imaging may provide improved sensitivity and specificity
for microscopic nodal involvement. At present, we use ultrasound
for assessment of nodal disease and core biopsy to document
metastases if the nodes are morphologically abnormal.
Effect on treatment
At the University of Chicago, we followed 140 consecutive
patients with noninflammatory cancer who underwent MR
breast examination. In 40 (28.6%) of these patients, additional
cancers were found on the MR study. Of those, 26 were found in the
same quadrant as the initial cancer, 11 were in a different
quadrant, and 3 were found in the contralateral breast. These
findings altered therapy in 31 patients: 20 had larger
lumpectomies than had been initially planned, 8 were determined to
require mastectomy, and 3 were changed to neo-adjuvant treatment.
4
With MR, additional cancer is found in approximately 30% of
patients. This means that in roughly 70% of patients we can be
confident that the cancer is confined to the
extent determined prior to the MR study. That is important
information when considering focal radiation treatment. MR imaging
has a positive and reinforcing effect in cases in which the disease
is truly unifocal. For these patients, alternative therapies, such
as ablation procedures and more focal radiation therapy, may be
options.
Other indications
MR can also be used to evaluate a patient for residual cancer.
Typically following surgery, a seroma cavity will be visible;
enhancement of the seroma rim, typically 2 to 3 mm in thickness, is
usually seen. Patients with positive margins should be imaged as
soon as they can tolerate lying in the magnet. In these patients,
mammography is not going to be useful, except perhaps in cases of
DCIS in which the clinician is looking for residual
calcifications. Noncalcified lesions will not
be visible on a mammogram because of the presence of the large
seroma cavity. In addition, the inability to obtain adequate
compression in a postoperative patient will further limit
mammography's usefulness in these patients.
MR can also be used to locate a small primary lesion in patients
who present with palpable nodes or to assess for recurrent tumors.
Many of these "recurrent tumors" may actually be tumors that were
present but not initially detected or treated. It can also be used
to assess patients who are difficult to image with
mammography and/or ultrasound because of other factors, such as
deformity, scarring, and postsurgical changes to the breast tissue.
For such patients, it can often be much easier to make a diagnosis
with MR imaging.
Postsurgical follow-up of certain patients may also be an
indication for MR imaging, particularly if the initial cancer was
mammographically occult. MR can also be used to measure response to
tumor therapy. A study by Warren et al
5
showed that sensitivity and specificity of MR were
superior to conventional imaging for monitoring response to
chemo-therapy.
Conclusion
In our institution, MR imaging of newly diagnosed breast cancer
patients has become routine practice. The surgical, medical, and
radiation oncologists now depend on the information provided by MR
to assist them in formulating de-finitive treatment
measures. MR screening of high-risk women is also an important role
for breast MR imaging. It is probable that higher
field-strength magnets, innovative protocols, and new
contrast agents will continue to improve and expand the
applications for breast MR imaging in the future.
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