U.S. Multi-site clinical trial launched to evaluate 3D whole breast US system

The University of Southern California (USC) Norris Comprehensive Cancer Center in Los Angeles has launched a new clinical trial to determine the effectiveness of a 3-D whole-breast ultrasound system designed to assist radiologists in identifying breast cancer. It is one of eight sites in the United States starting to recruit at least 10,000 asymptomatic women over the age of 18 with dense breast tissue to participate. Enrollment in the observational study, which is expected to be completed in March 2019, began in August 2017.

The objective of the clinical trial (NCT03257839) is to determine if the SoftVue™ 3D whole-breast ultrasound system (Delphinus Medical Technologies) can identify breast cancer in women with dense breasts, to establish a library of cases for use in future SoftVue research studies, and to determine the frequency and severity of adverse events to further evaluate the safety of SoftVue.

Participants will have a routine mammography screening examination followed by an examination with SoftVue. For the latter, a woman lies prone on her stomach with her breast supported in a warm water bath. A 360-degree ring transducer images the entire breast in a single pass, moving from the front of the breast to the chest wall. The entire scan takes about two to four minutes per breast.

Principal investigator Mary W. Yamashita, MD, assistant professor of clinical radiology, said, “Our hope is that this technology will enable us to detect cancers much sooner in women with dense breast tissue so that we can provide better outcomes for those with cancer and peace of mind for those with a negative study. More than 40% of women in the United States have dense breast tissue.”

In addition to Lee Breast Center at USC Norris Comprehensive Cancer Center, participating sites include:

• Beaumont Health Dearborn Breast Care Center - Dearborn, MI
• Elizabeth Wende Breast Care - Rochester, NY
• Miami Mount Sinai Medical Center - Miami Beach, FL
• Saint Elizabeth Hospital - Appleton, WI
• SouthCoast Imaging - Savannah, GA
• University of North Carolina - Chapel Hill, NC
• Weinstein Imaging - Pittsburgh, PA

Information about enrollment may be obtained by calling 323-442-9299. Delphinius Medical Technologies is a sponsor of this clinical trial.