SOMO•INSIGHT is a multi-center nationwide clinical research study sponsored by U-Systems, Inc. to evaluate if the somo•v Automated Breast Ultrasound (ABUS) done together with a routine screening mammogram (x-ray) is more accurate in detecting breast cancer in women with dense breast tissue than having a routine screening mammogram alone. The fully automated ultrasound technology, which is used in the clinical research study is cost effective and patient friendly. The somo•VIEWer™ software creates 3D-reconstructed images of the breast tissue for the radiologist to review.

 

The purpose of the SOMO•INSIGHT Study is to determine if combining somo•v ABUS together with routine screening mammography is more sensitive to detecting breast cancer in women who have dense breast tissue, than routine screening mammography without somo•v ABUS in women who have dense breast tissue. A portion of the data collected will be used in support of a new SCREENING Indication for Use from the United States Food and Drug Administration. If approved, somo•v ABUS will be the first and only ultrasound device with a breast cancer screening indication. Once the study is complete, all of the data will be analyzed and the results will be published in peer-reviewed medical journals. These publications, together with reports from other breast ultrasound studies, may help the medical community convince insurance payers of the benefits of somo•v Automated Beast Ultrasound screening so that reimbursement is available for these exams.

The study has enrolled more than 15,000 asymptomatic women with dense breast tissue at more than 10 clinical research sites across the nation. A statistically significant number of breast cancers have already been detected under the research protocol, which has brought the trial to its endpoint more than 5,000 subjects sooner than initially anticipated. This study is in direct response to the need for more effective and practical breast cancer screening methods in women with dense breasts.

The hypothesis tested under the study protocol is that a higher sensitivity to breast cancer detection can be achieved in women with dense breast tissue by performing and reviewing results of ABUS and digital mammography together as part of route screening, compared to performing and reviewing results of digital mammography lone.

 

According to the New England Journal of Medicine¹, “Extensive mammographic density is strongly associated with the risk of breast cancer detected by screening or between tests. A substantial fraction of breast cancers can be attributed to this risk factor.” While mammography remains to be the gold standard, JAMA² has stated, “Automated whole breast ultrasound may facilitate implementation and profitability of screening ultrasound.”

 

Literature has shown improved early detection of breast cancer when ultrasound is used as an adjunct to mammography for women with dense breast tissue. Dr. Pavel³ has reported, “Screening breast sonography in the population of women with dense breast tissue is useful in detecting small breast cancers that are not detected on mammography or clinical breast examination. The use of sonography as an adjunct to screening mammography in women with increased risk of breast cancer and dense breasts may be especially beneficial.”

 

It is anticipated that the SOMO•INSIGHT Clinical Study will prove that the somo•v ABUS is an essential tool and will make a positive difference in women’s health-care.

To learn more about the SOMO•INSIGHT Clinical Study, visit http://www.somoinsightstudy.org or email us at inquiries@u-systems.com.

 

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¹ New England Journal of Medicine 2007;356:227-36

² JAMA 2008;299(18):2151-63

³ Pavel; Using Sonography to Screen Women with Mammographically Dense Breasts.