A Clinical Study to Evaluate Somo•v and Digital Mammography Together as a Breast Cancer Screening Method, Compared to Digital Mammography Alone, in Women With Dense Breasts.

Launched by U-SYSTEMS, INC. · Dec 31, 2008

Keywords

ClinConnect Summary

This is a study to determine if having somo٠v™ (U-Systems, Inc.) Automated Breast Ultrasound (ABUS) done together with a routine screening mammogram, is more sensitive to detecting breast cancer in women with dense breast tissue than getting a routine screening mammogram without ABUS. Potential study volunteers will be recruited at participating breast centers from the cohort of asymptomatic women who are scheduled to undergo routine screening mammography.

Breast cancer is one of the most commonly diagnosed cancers in American women with an estimated 210,000 new cases diagnosed in 2007. De...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female
• • Asymptomatic
• • Prior screening mammograms, if available, exhibit history of breast density
• • Not currently pregnant or breastfeeding
• • Not planning to become pregnant in the following 18 months
• • Age 25 or older
• • No breast surgeries or interventional procedures in the past 12 months
• • No history of cancer diagnosis and/or treatment in the past 12 months
• • Informed Consent and Completed Participant Questionnaire
• • Complete screening mammography views (CC and MLO) for one or both breasts
• • \> 50% preliminary parenchymal density on preliminary assessment by technologist
• * Willing to comply with study protocol and follow-up recommendations:
• • If evaluation is normal, must undergo routine screening mammography in 12 months
• • If evaluation is abnormal, must undergo additional imaging and diagnostic procedures recommended by the Investigator, including but not limited to a biopsy and routine screening mammogram in 12 months if findings are benign.
• • Agrees to report any breast changes or symptoms to the Investigator for the 12 months following study enrollment until and including completion of routine screening mammogram.
• • Agrees to be contacted by site study staff if routine screening mammography or recommended follow-up is not completed within the recommended time frame.
• Exclusion Criteria:
• • ≤ 50% preliminary parenchymal density on preliminary assessment by technologist
• • Does not meet all Inclusion Criteria for Enrollment