NCT01106911

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

Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,080 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Abnormalities

Interventions

Type	Name	Description
DEVICE	tomosynthesis and screening mammography	All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-09-01
• First posted: 2010-04-20
• Last updated: 2016-03-25
• Results posted: 2016-03-25

Locations

1 site across 1 country: United States