Breast Abnormalities Clinical Trial
Official title:
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study
The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.
The FFDM images and the FFDM images with the DBT images will be interpreted independently by two experienced radiologists under standard clinical screening procedures. Recommended recall rates will be assessed and compared as a result of each of the two interpretations. ;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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