Trial Information

To Determine the Clinical Impact of the Combination of Digital Breast Tomosynthesis and Digital Mammography on Screening for Breast Cancer

The investigators would like to prospectively measure the impact on recall rates, comparing
DM (digital mammography) and DM+DBT, in our practice and the impact on cancer detection in
our screening population. This is a two-site study in which all asymptomatic subjects
undergoing the FDA-approved combination standard of care Digital Mammogram and Digital
Breast Tomosynthesis (DM+DBT) exam will be eligible for the trial. Each subject will be her
own control.Only radiologists who have gone through 8 hours of Tomosynthesis training will
interpret the DM and DBT images. These radiologists will categorize each case as either
dense (BI-RADS density score of 3 or 4) or fatty (BI-RADS density score of 1 or 2). The
radiologist will initially read the standard of care DM part of the study first and record
their interpretation and final BIRADs category. The same radiologist will then interpret the
DM+DBT combination study and record their final interpretation and BIRADs category. Prior
mammogram studies will be used for comparison when reading the DM and DM+DBT studies.