Delphinus Medical Technologies announced on Thursday that the SoftVue Discover Breast Ultrasound Prospective Case Collection project enrolled its first patient.

This study is comparing SoftVue 3-D whole breast ultrasound to digital mammography in terms of its ability to detect additional cancer not seen with mammography alone, particularly in women with dense breasts.

In total, 10,000 asymptomatic women with dense breasts at several centers in the U.S. will be enrolled. Those centers include USC Norris Comprehensive Cancer Center, Mt. Sinai Medical Center, Beaumont Hospital - Dearborn, Elizabeth Wende Breast Care, Southcoast Health Imaging, St. Elizabeth Hospital, part of Ascension and Weinstein Imaging.
Delphinus will use the data from this study to seek FDA approval for a supplemental screening indication for women with dense breasts, in conjunction with mammography.

SoftVue is already FDA-cleared for diagnostic breast ultrasound imaging, but is currently only in use at the centers participating in the study.

During a SoftVue exam, the patient lies on their stomach on a padded table with their breast suspended in a warm water bath. A 360-degree ring transducer scans the entire breast in two to four minutes.

Unlike mammography, the patient isn't exposed to radiation and compression is not required. Compared to handheld ultrasound, SoftVue is able to provide radiologists with multiple distinctive tissue qualities so they can differentiate cancer from benign lesions.

“This important research will help us confirm the efficacy of the SoftVue system and potentially help establish new standards of care in dense breast tissue cancer screening," Dr. Mary Yamashita, assistant professor of clinical radiology at USC Norris Comprehensive Cancer Center and the national principal investigator of the study.

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