Trial Information

Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial

This prospective national multicenter multivendor trial aims at determining the impact of
the novel technique Digital Breast Tomosynthesis (DBT) in the assessment and screening for
breast cancer. Mammography is the primary imaging modality for the early detection of
clinically occult breast cancer.

Despite advances in mammographic technique, mammography is still limited with regard to both
sensitivity and specificity. In the majority of cases these limitations arise from the
masking of subtle breast cancer lesions by overlapping breast tissue.

DBT is a novel technique that tries to overcome these limitations by performing a
3D-reconstruction of breast tissue from multiple low-dose digital mammographic images
acquired in several planes in a 15 to 50 degree angle.

Early studies indicate an advantage of DBT compared to the standard Full Field Digital
Mammography (FFDM) in terms of an improvement of specificity without cutback in sensitivity.

Controversy continues over the use of DBT in combination with FFDM or as a standalone
screening method without concomitant 2D imaging. Unfortunately, the peer-reviewed
publications evaluating DBT are limited and consist of single institution studies with a
small number of participants.

The purpose of this study is to evaluate the novel technique of DBT compared to routine FFDM
in a clinical large sample study (600 participants) to provide the path to implementation of
this new technique into clinical and screening routine.