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.

Completed

Conditions studied: Breast Cancer

In brief

Hypothesis: A higher sensitivity to breast cancer detection can be achieved in women with dense breast tissue by performing and reviewing results of Automated Breast Ultrasound (ABUS) and Digital X-Ray Mammography (XRM) together as part of routine screening compared to performing and reviewing results of XRM alone. Primary Objective: For the cohort of asymptomatic women who have dense breast tissue, calculate the sensitivity of Digital X-Ray Mammography (XRM) and ABUS together as a breast cancer screening modality and compare it to that of XRM alone. Secondary Objective: For the cohort of asymptomatic women who have dense breast tissue, evaluate the specificity of XRM and ABUS together compared to that of XRM alone; Calculate the negative predictive value (NPV) and positive predictive value (PPV) for XRM and ABUS. Endpoint: Breast cancers detected by radiologists in the clinical screening setting and confirmed by pathology. Study Design: This is a prospective matched-pair clinical study enrolling more than 20,000 women with parenchymal density \> 50% on digital x-ray mammography (XRM). Participants will receive ABUS as an adjunct to XRM. Any abnormal findings, from either XRM or ABUS, will receive appropriate management action consistent with accepted medical standards of care. All evaluation results, diagnosis and treatment outcomes will be recorded. Participants will be followed for one year and those who are not diagnosed with breast cancer at enrollment or during the follow-up interval must undergo an annual mammogram at study completion, the outcome of which will be recorded.

Key facts

Study ID

NCT00816530

Run by

U-Systems, Inc.

People needed

15679

Starts

2009-03-01

Expected to finish

2012-12-01

Last updated by the study team

2014-12-02

Who can join

Age: 25 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• ≤ 50% preliminary parenchymal density on preliminary assessment by technologist
• Does not meet all Inclusion Criteria for Enrollment

Where it is running

• Solis Women's Health — Indio, California, United States
• Community Hospital of the Monterey Peninsula — Monterey, California, United States
• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Boca Raton Community Hospital — Boca Raton, Florida, United States
• Radiology Regional Center — Fort Myers, Florida, United States
• OSF Saint Francis Centers for Breast Health — Peoria, Illinois, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Women's Imaging Centre — Lafayette, Louisiana, United States
• Henry Ford Hospital System — Detroit, Michigan, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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