Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Abnormalities
- Sponsor
- University of Pittsburgh
- Enrollment
- 1080
- Locations
- 1
- Primary Endpoint
- Number of Participants Without Cancer Who Were Recalled
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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%.
Detailed Description
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.
Investigators
Jules Sumkin
Chief of Women's Imaging
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Women between the ages of 34 and
- •Women presenting for their baseline screening mammography examination
Exclusion Criteria
- •Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical Breast Examination (CBE).
- •Women who may be or are pregnant by self report
- •Women older than 55 years of age or younger than
- •Women with known fatty breast tissue
- •Males and children
- •Women who are unable to understand or execute written informed consent
Outcomes
Primary Outcomes
Number of Participants Without Cancer Who Were Recalled
Time Frame: upon recruitment/enrollment phase completion
Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.