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. (somo•InSIGHT)
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.
|Breast Cancer||Device: Automated Breast Ultrasound (ABUS) as an adjunct to digital screening mammography|
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Prospective Multicenter Matched-pair Clinical Study to Evaluate the Sensitivity and Specificity of ABUS and Digital X-Ray Mammography (XRM) Together as a Breast Cancer Screening Method Compared to XRM Alone in Women With >50% Parenchymal Density.|
- For the cohort of asymptomatic women who have dense breast tissue, calculate the sensitivity of XRM and ABUS together as a breast cancer screening modality and compare it to that of XRM alone. [ Time Frame: 18 months ]
- 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. [ Time Frame: 30 Months ]
|Study Start Date:||March 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Asymptomatic Women who have Dense Breast Tissue
Women who have no signs or symptoms of breast cancer who have > 50% parenchymal density on mammography.
Device: Automated Breast Ultrasound (ABUS) as an adjunct to digital screening mammography
After density > 50% is confirmed by routine digital screening mammography, ABUS will be performed.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00816530
|United States, California|
|Solis Women's Health|
|Indio, California, United States, 92201|
|Community Hospital of the Monterey Peninsula|
|Monterey, California, United States, 93942|
|United States, District of Columbia|
|George Washington University Medical Center|
|Washington, District of Columbia, United States, 20037|
|United States, Florida|
|Boca Raton Community Hospital|
|Boca Raton, Florida, United States, 33486|
|Radiology Regional Center|
|Fort Myers, Florida, United States, 33919|
|United States, Illinois|
|OSF Saint Francis Centers for Breast Health|
|Peoria, Illinois, United States, 61615|
|United States, Kansas|
|Kansas University Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Louisiana|
|Women's Imaging Centre|
|Lafayette, Louisiana, United States, 70508|
|United States, Michigan|
|Henry Ford Hospital System|
|Detroit, Michigan, United States, 48202|
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98111|
|Principal Investigator:||Rachel F Brem, MD||George Washington University|