U-Systems, a breast ultrasound systems developer, and Rachel F. Brem, MD, professor of radiology, director of the breast imaging and interventional center at the George Washington University Medical Faculty Associates in Washington, D.C., have enrolled the first participants in the SOMO·INSIGHT clinical study.
With an estimated enrollment of 20,600, SOMO·INSIGHT will examine whether full-field digital mammography, along with the somo•v automated breast ultrasound system (ABUS), can improve breast cancer detection when compared with mammography alone in women with dense breasts, according to the San Jose, Calif.-based U-Systems.
Specifically, the cohort will include women who have no signs or symptoms of breast cancer and who have less than 50 percent parenchymal density on mammography.
"This is especially exciting as the somo•v ABUS is a quick test that uses no radiation and has the potential to significantly improve breast cancer detection," said Brem, principal investigator for the study.
Participants will receive ABUS as an adjunct to x-ray mammography (XRM). Any abnormal findings, from either XRM or ABUS, will receive appropriate management action consistent with accepted medical standards of care. All evaluation results, diagnosis and treatment outcomes will be recorded. Participants will be followed for one year and those who are not diagnosed with breast cancer at enrollment or during the follow-up interval must undergo an annual mammogram at study completion, the outcome of which will be recorded, according to Brem and U-Systems.