June 22, 2009 - U-Systems, a dedicated breast ultrasound systems manufacturer, together with Medical Director Jessica A. Guingrich, M.D., of OSF Saint Francis Medical Center, Susan G. Komen Breast Center and Centers for Breast Health have initiated the SOMO·INSIGHT Clinical Study, designed to examine whether digital mammography along with the somo•v Automated Breast Ultrasound (ABUS) is more sensitive to detecting breast lesions when compared to mammography alone in women with dense breasts.
The first participants have been enrolled and the first pathologically confirmed cancer has been detected in a mammographically-negative screening patient. The initiation of this nationwide study, which intends to recruit over 20,000 women, is an important milestone for U-Systems in evaluating new approaches to improved cancer detection. Screening mammography can be limited in women with dense breasts and these women have a higher risk of breast cancer. ABUS uses ultrasound (sound waves) at a reportedly safe frequency to create images of the internal breast tissue, unlike mammography, which uses radiation. Ultrasound has been shown to find cancer not visible with mammography in women who have dense breasts. A new approach to improving breast cancer detection is critical for women with dense breasts who undergo mammography. It is for this reason that U-Systems developed the somo•v and is sponsoring the SOMO·INSIGHT clinical study.
Jessica A. Guingrich, M.D., principal investigator for the SOMO·INSIGHT Clinical Study at OSF stated, “We are excited to be a part of this clinical study and to be able to bring new technology for earlier cancer detection to our patients. Shortly after initiating the clinical study, we identified the first pathologically-confirmed cancer in a mammographically negative patient. Fortunately, the patient was enrolled in the SOMO·INSIGHT study and the somo•v Automated Breast Ultrasound identified a region of interest which was confirmed on biopsy to be an Infiltrating Ductal Carcinoma of the Breast. The patient is now undergoing treatment for this cancer.”