The American Cancer Society estimates that there will be >211,000 new cases of breast cancer diagnosed this year and that >40,400 women will die of this disease.1 Early detection is key to long-term survival for these women. Two new tools designed to assist the radiologist in making an early diagnosis have been introduced recently: The ﬁrst computer-aided detection (CAD) system for breast ultrasound, and a new picture archiving and communications system (PACS) with a workstation designed to meet the requirements for soft-copy diagnosis of mammography.
The American Cancer Society estimates that there will be
>211,000 new cases of breast cancer diagnosed this year and that
>40,400 women will die of this disease.
Early detection is key to long-term survival for these women. Two
new tools designed to assist the radiologist in making an early
diagnosis have been introduced recently: The first computer-aided
detection (CAD) system for breast ultrasound, and a new picture
archiving and communications system (PACS) with a workstation
designed to meet the requirements for soft-copy diagnosis of
CAD for breast ultrasound
Cedara Software Corp. (Toronto, Ontario, Canada), a division of
Merge Healthcare, recently received FDA approval to begin marketing
the first CAD software designed specifically for use with breast
"Cedara B-CAD is the first breast ultrasound CAD product of its
kind," said Sabrina Cannistraro, Cedara's Product Manager for
Women's Health. "We developed it because we saw a need in the
market. There are CAD products out there for mammography and for
magnetic resonance imaging [MRI]-both of which are widely used
modalities in breast imaging-but there was nothing out there for
CAD for ultrasound."
The company hopes that this new software will help reduce the
number of unnecessary breast biopsies performed. "Typically, a
patient will go for her regular screening mammogram," explained
Cannistraro. "If something suspicious is found, she'll go either
for diagnostic mammograms or for an ultrasound or, possibly, an
MRI. Ultrasound is generally the standard modality used for making
a 'biopsy versus do-not-biopsy' decision. Currently, roughly 1
million biopsies are performed in the United States each year, and
80% of them are negative. Therefore, we thought it was important to
give radiologists more information at the point of ultrasound to
help them make a better decision regarding biopsy."
The B-CAD software provides automated segmentation,
characterization, classification, annotation, and report generation
for a defined lesion within a specified image. "The radiologist
defines the region of interest, and the system automatically finds
those characteristics and displays it on the screen," explained
Cannistraro. The software places markers on the image and, on a
checklist on the side of the user interface, checks those
characteristics that have been found (Figure 1). The radiologist
can accept or reject any of the checked characteristics based on
his or her own interpretation of the image.
The system can also provide its own suggestion as to whether or
not a biopsy should be performed. "The radiologist obviously makes
his or her own decision at that point," said Cannistraro. "CAD does
not make the ultimate decision. But now the radiologist has a
little bit more information with which to make that decision. All
of this analysis happens within 5 to 10 seconds and can be done
while the patient is still in the room."
The system includes the option of adding annotations based on
the Stavros criteria, as well as the American College of Radiology
(ACR) Breast Imaging and Reporting Data System (BIRADS) Breast
Imaging Atlas. The report form also supports compliance with the
new ACR BIRADS Ultrasound Lexicon, which is expected to be adopted
as the standard reporting format by the Mammography Quality
Standards Act (MQSA).
"This tool should facilitate acceptance and utilization of the
ACR BIRADS Ultrasound Lexicon by radiologists as a standard upon
which the foundation of CAD-enabled ultrasound can be built," said
A. Thomas Stavros, MD, of The Sally Jobe Breast Center in Denver,
CO. "Ultrasound CAD has many possible indications, including
assisting radiologists in the analysis of solid breast nodules,
which is a significant first milestone. This tool may improve a
radiologist's interpretive confidence."
"We can see how a lexicon was developed in mammography and is
now required reporting procedure in the United States. In a similar
vein, the ultrasound lexicon is increasingly becoming developed,
but there are people who are having challenges with identifying all
of the unique characteristics that are identified in the lexicon
and they aren't overly familiar with it," noted Kevin Clark,
Manager of Marketing and Product Communications, Merge Healthcare.
"Consequently, B-CAD acts as an excellent training tool and a
reminder of all of these different elements that need to be taken
into account to read breast ultrasound. Breast ultrasound can be a
challenge to report. Being able to identify all the different
characteristics of a lesion or calcification is very important. But
it is also getting the specifics-being able to look at the
topography of the actual lesion-that is a key factor that a lot of
people are missing out on."
The system, which is expected to be commercially available in
October, will be offered in several configurations. It will be
available as a component that can be integrated into any
DICOM-compliant workstation or ultrasound system, or as an
installed feature on the Cedara I-ReadMammo workstation. The
company also plans to offer the software to the OEM community,
allowing other companies to provide B-CAD as a feature on their
PACS or ultrasound systems.
Kodak PACS for mammography
The Eastman Kodak Co. (Rochester, NY) recently introduced its
new DirectView PACS System 5 for Mammography and its multimodality,
vendor-neutral DirectView Mammography Workstation. "With this PACS,
the major thing that is unique for mammography is the workstation,"
explained Jane Hasselkus, U.S. and Canada Business
Manager for Women's Health and Oncology, Kodak's Health Group.
"Until now, most PACS workstations have used 3 megapixel (MP)
monitors with software designed for viewing general X-rays,
computed tomography [CT], and MRI. All the tools and hanging
protocols have been set up for those types of examinations. The new
diagnostic workstation for mammography includes 2 or 4 5-MP
monitors-which the FDA has required for proper viewing for
diagnostic and screening mammography-and has hanging protocols and
tools that are specific for digital mammography."
"This new workstation can not only display images from different
modalities (such as ultrasound, MRI, general X-ray exams from a
computed radiography or digital radiography system, and CT), but it
can also show images from all of the full-field digital mammography
systems. It is completely vendor-neutral," continued Hasselkus. "In
a very busy hospital, the mammography department is usually quite
space-constrained, so the ability to have one workstation on which
you can view all of those different modalities is really quite
The DirectView PACS System 5 for Mammography platform allows
PACS users to integrate digital mammography examinations into
general radiology workflows. It provides all users with immediate
access to current patient images and information with seamless
radiology information system (RIS) integration via a brokerless
HL-7 interface with worklists and RIS data displayed on a
flat-panel administrative monitor.
In addition to the PACS systems, Kodak also markets an
enterprise RIS solution and is expected to release a second RIS
designed specifically for imaging centers soon. "Features that are
specific to mammography, such as BIRADS reporting capabilities, are
built into the imaging center RIS and are available as an option on
the enterprise RIS," noted Hasselkus. "So we'll have an integrated
RIS/PACS solution that we will be able to offer to customers."