Mary Yamashita, left, and Shauna Lee talk in front of the SoftVue machine

Mary Yamashita, left, and Shauna Lee talk in front of the SoftVue machine

A new research project at USC Norris Comprehensive Cancer Center is actively recruiting women with dense breast tissue to examine the effectiveness of a novel breast ultrasound device. SoftVue is the world’s first 3-D, whole-breast ultrasound system that might better assist physicians in distinguishing normal breast tissue from cancers.

“While mammography is the best screening tool for women, we have known for years that breast cancers are much more difficult to see in women with dense breasts,” said Mary Yamashita, MD, assistant professor of clinical radiology at the Keck School of Medicine of USC and the national principal investigator of the research project. “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 percent of women nationwide have dense breast tissue, which is unrelated to weight or breast size. Because dense breasts can mask potential cancers on mammography, the sensitivity for detecting cancer is lower in women with dense breasts. Handheld ultrasound can detect cancers not seen on mammography, but these exams can be time-consuming and are operator-dependent. They also have a high rate of false positives, resulting in unnecessary biopsies.

SoftVue is a faster, more automated system that conducts scans while the woman is face down with her breast supported in a warm water bath. A 360-degree ring transducer images the entire breast in a single pass within two to four minutes per breast without radiation exposure or compression. Unlike handheld ultrasound, SoftVue can provide multiple distinctive tissue qualities to radiologists, allowing them to differentiate possible cancers from normal to benign findings.

“I was not sure what to expect, but the SoftVue exam was both easy and comfortable,” said Shauna Lee, the first patient enrolled in this arm of the clinical trial. “I am hopeful that this ultrasound could be the new standard of care for women with dense breasts, and I would encourage other women who qualify to enroll in this trial.”

The 10,000-patient nationwide clinical trial will be open at eight sites across the United States, with USC Norris being the only site in Southern California. Women who have been notified about having dense breast tissue on mammography are encouraged to enroll by calling (323) 442-9299 or emailing softvue@usc.edu.

By Mary Dacuma