Published on February 14, 2011 at 9:55 AM
The Reader Study cases were collected under the SOMO•INSIGHT Clinical Study, which is the largest prospective clinical trial ever undertaken by an ultrasound company. The SOMO•INSIGHT Clinical Study was, designed to evaluate whether digital mammography in combination with somo•v ABUS is more sensitive than a routine screening mammogram alone in detecting breast cancer in women with dense breast tissue. To date, more than 12,000 women have participated in the study which is actively recruiting up to 20,000 women at multiple breast imaging centers nationwide. To date, the study has identified a significant number of mammographically negative breast cancers that were subsequently detected by ABUS
"While ultrasound is a proven tool throughout the diagnosis and treatment of breast cancer, it has not typically been used during the screening process. However, for women with dense breast tissue several large studies have shown that supplementing mammograms with ultrasound can increase detection from 48 to 97 percent," added Ho. "New approaches to improve early detection in women with dense breasts are clearly needed. We have dedicated significant time and resources to establishing a solid scientific basis for the use of ABUS as a cancer screening tool for women with dense breast tissue."
A growing body of research demonstrates a strong link between breast density and increased cancer risk; up to 4-6 times in one study (Boyd, et al. New England Journal of Medicine 2007;356:227-36M) The study, published in the New England Journal of Medicine , showed 35 percent of breast cancer goes undetected by mammography in women with dense breasts as density masks the appearance of tumors. Since both dense breast tissue and cancer appear white on a mammogram, it is difficult to detect cancer when there is increased dense breast tissue. As breast density increases, the accuracy of the mammogram decreases.