March 14, 2011 – A pivotal ROC reader study for automated breast ultrasound cancer screening has been completed. The multi-reader, multi-case (MRMC) study evaluated the sensitivity of the somo•v Automated Breast Ultrasound (ABUS) together with a screening mammogram in detecting breast cancer in women with dense breast tissue
The study was conducted by the University of Chicago for U-Systems.
“For most women, mammography remains the gold-standard for the early detection of breast cancer, but multiple studies have demonstrated that it is not enough for women with dense breast tissue,” said study principal investigator Maryellen Giger, Ph.D., professor of radiology at the University of Chicago. “The primary objective of this reader study was to determine the impact of ABUS on reader (interpreting physician) performance when used in combination with mammography as a screening modality for asymptomatic women with dense breast tissue. This study brings us one step closer to earlier detection of breast cancer using ultrasound as an adjunctive screening tool.”
The study data will be used to support the company’s pre-market approval (PMA) submission to the U.S. Food and Drug Administration (FDA) for the ABUS technology. The company will seek a new indication for using the system in screening women with dense breast tissue. It is currently FDA 510(k)-cleared for adjunctive diagnostic use with mammography.
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 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,” said Ron Ho, president and CEO of U-Systems. “New approaches to improve early detection in women with dense breasts are clearly needed.”
A growing body of research demonstrates a strong link between breast density and increased cancer risk – up to four to six times in one study published in the New England Journal of Medicine. 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.