Recent advances in digital imaging, including but not limited to Full Field Digital Mammography (FFDM), has enabled a relatively easy implementation of Digital Breast Tomosynthesis (DBT) technology into the clinical practice. DBT based imaging alone and /or in combination with FFDM is of great interest in screening as well as in diagnostic breast imaging for several reasons. To date questions remain regarding the role that DBT may ultimately play in breast imaging. It is clear that significant work needs to be done in terms of both the systems themselves and, as important perhaps, how to best manage and display the generated image data. However, at this time it is most important to confirm in a prospective clinical study the demonstrated potential for a significant decrease in recall rates when using DBT, as shown in retrospective studies. The purpose of this project is to address this very point by performing a limited prospective study on women who are most likely to benefit from the inclusion of DBT in the screening environment. We propose to assess and compare the recall rates in younger women (<55YO) participating in their initial breast screening examination. The work proposed here is aimed primarily at the use of DBT imaging in combination with FFDM in the screening environment, but this project has broad and potentially significant implications on diagnostic breast imaging as well.
This is a prospective study to test the hypothesis that the use of DBT in the screening environment actually reduces recall rates by at least 20%. A unique study design will enable the testing of this primary hypothesis, as well as important clinically relevant secondary hypotheses, on the group of women who are most likely to benefit from this imaging and examination management approach.