Delphinus Medical Technologies, Inc., the leader in advanced breast ultrasound technology, announced today that the SoftVue™ Discover Breast Ultrasound Prospective Case Collection project has launched, enrolling the first patient. Qualified participants will undergo screening digital mammography as well as SoftVue 3D whole breast ultrasound exams. Information gathered from the project will compare SoftVue imaging to digital mammography to determine the effectiveness of detecting additional cancers with SoftVue that are not seen with mammography alone, particularly in women with dense breast tissue.
The project will enroll 10,000 asymptomatic women with dense breast tissue at several centers in the U.S. More than 40 percent1 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. Studies have shown that in dense breasts, ultrasound can detect cancers not seen on mammography. However, traditional handheld ultrasound exams can be time consuming and often operator dependent. They also have a high rate of false positives, resulting in unnecessary biopsies and added cost to the healthcare system.
In contrast, SoftVue is a fast, fully automated, and gentle system that conducts scans while a woman lies on her stomach on a padded table, 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 and there is no radiation exposure or compression of the breast. Unlike handheld ultrasound, SoftVue can provide multiple distinctive tissue qualities to radiologists, allowing them to differentiate possible cancers from normal to benign findings.