Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment
Recruitment status was Recruiting
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%.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study|
- recall rates [ Time Frame: upon recruitment/enrollment phase completion ] [ Designated as safety issue: No ]Recall rates and specificity of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.
|Study Start Date:||May 2010|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Device: tomosynthesis and screening mammography
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106911
|Contact: Linda Lovy, RT(R)(M)(CT), RDMS(BR)||(412)firstname.lastname@example.org|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Linda Lovy 412-641-6966 email@example.com|
|Principal Investigator: Jules H Sumkin, DO|
|Principal Investigator:||Jules H Sumkin, DO||University of Pittsburgh|