Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy
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Comparison of the ability of DBT and FFDM to detect breast cancer.
Condition or disease
Enrolled women will undergo bilateral DBT. Prior breast imaging data (screening and diagnostic mammography) must have been conducted on GE equipment and the images must be available (or imaging must be repeated). DBT images will be read on-site by one or more qualified radiologists. All subjects who undergo biopsy will be asked to return in approximately 1 year for a follow-up mammogram. Images will be processed and evaluated by independent readers.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Women referrd for breast biopsy because of one or more abnormalities seen on routine screening mammography; who are also asymptomatic
Women ≥18 years or older and has underwent screening/diagnostic mammography and referred for breast biopsy
Able and willing to comply with study procedures, and have signed and dated the informed consent form
Surgically sterile or postmenopausal
Pregnant or trying to become pregnant
Has signs or symptoms of breast cancer
Has been previously included in this study
Has breast implants
Has a history of breast cancer and is in active treatment
Has breasts too large to be adequately positioned for the DBT examination