Somo-InSIGHT Study, Breast Cancer Screening Study Beginning Early 2009 Enrolling Over 20,000 Women

Main Category: Breast Cancer
Also Included In: Radiology / Nuclear Medicine;  MRI / PET / Ultrasound
Article Date: 25 Nov 2008 - 6:00 PDT

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U-Systems, the innovative leader in dedicated breast ultrasound systems, today announced its plans to conduct a multi-center breast cancer screening study named somo•InSIGHT, with more than 20,000 women, using its proprietary Automated Breast Ultrasound System (ABUS). U-Systems is responding to the clinical need for an automated breast ultrasound solution for screening women with dense breast tissue. The clinical study, entitled The somo•InSIGHT Study, will evaluate the sensitivity and specificity of X-Ray Mammography (XRM) and Automated Breast Ultrasound (ABUS) together, as compared to XRM alone, as a breast cancer screening method in women with greater than 50% parenchymal density.

Ron Ho, the President and CEO of U-Systems said, "We know that screening dense breasts with mammography alone is a challenging clinical problem today and we believe that the use of somo•v™ as an adjunct to mammography could assist the radiologist in the earlier detection of cancer for this large group of asymptomatic women. I am excited about the opportunity to significantly improve the early detection of breast disease with U-Systems' advanced and proprietary technology."

Rachel Brem, MD, Director of Breast Imaging and Interventional Center of George Washington University, will be the Principal Investigator for the study. Dr. Brem said, "It is the commitment of U-Systems to evaluate in a scientific and rigorous manner the potential of Automated Breast Ultrasound for screening low risk women with dense breasts."

Published literature has shown improved early detection of breast cancer when ultrasound is used as an adjunct to mammography for women with dense breast tissue. However, an automated breast ultrasound system is needed to screen women with mammographically dense breasts and whose cancer may not be visible with mammography.

"We are initiating this multi-center study with our somo•v to address that population of women with dense breasts. This is an undertaking that U-Systems feels is vital in the battle to find cancers earlier and at a more curable stage," said Bob Foley, U-System's Vice President of Clinical Affairs. "We believe that the somo•InSIGHT Study will demonstrate that screening dense breasted patients with ABUS and XRM is more beneficial than XRM alone."

About U-Systems

U-Systems is the leader in developing and marketing dedicated breast ultrasound systems. The U-Systems Automated Breast Ultrasound System (ABUS) is currently cleared under 510(k). The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.

For more information, please visit our website at http://www.u-systems.com/.

U-Systems

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