A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 3. Women Undergoing Breast Biopsy
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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Amy Longcore
Study Director
GE Healthcare
United States: Food and Drug Administration
GE 190-003
NCT00535184
August 2007
February 2010
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