Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment

Not Applicable

Completed

• Conditions: Breast Abnormalities

• Registration Number: NCT01106911
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Study Start: 2010-05
• Primary Completion: 2014-09
• Results First Submitted: 2016-01-25
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-24
• Last Update Submitted: 2016-02-24
• Results First Posted: 2016-03-25
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1080

Inclusion Criteria

• Women between the ages of 34 and 56.
• Women presenting for their baseline screening mammography examination

Read More

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 35.
• Women with known fatty breast tissue
• Males and children
• Women who are unable to understand or execute written informed consent

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants Without Cancer Who Were Recalled	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.

Trial Locations

Locations (1)

Magee-Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States