The USC Norris Comprehensive Cancer Center is spearheading clinical trials of a new water mammogram technology for women with dense breast tissue.
USC Norris is the first of eight health centers nationwide to test SoftVue, the world’s first 3-D whole-breast ultrasound technology designed to help doctors distinguish 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,” Dr. Mary Yamashita, assistant professor of clinical radiology at USC and the national principal investigator for the SoftVue research project, said in a statement. “Our hope is that this technology will enable us to detect cancers much sooner in women with dense breast tissue.”
The SoftVue ultrasound device, which conducts scans while a woman relaxes on her stomach with her breast supported in a warm-water bath, was developed by venture-backed Delphinus Medical Technologies, based in Michigan.
DMT investors include Michigan companies Beringea, Hopen Life Sciences, North Coast Technology Investors and Arboretum Ventures.
The Norris Cancer Center, which began clinical trials in July with three doctors and two researchers, is now recruiting women with dense breast tissue. Clinical trials of the trademarked SoftVue are expected to take two years and involve as many as 10,000 women across the U.S.
When completed, the SoftVue study will be submitted to the U.S. Food and Drug Administration for approval as a supplemental screening indication for women with dense breasts in combination with mammography.
More than 40 percent of women nationwide have dense breast tissue, which can mask potential cancers on mammography, USC Keck Medicine officials said. If successful, the fast and comfortable SoftVue technology could augment mammography and handheld ultrasound as a standard of care in such women, they said.
Health business reporter Dana Bartholomew can be reached at firstname.lastname@example.org. Follow him on Twitter @_DanaBart.