Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates
Completed · Not applicable
Conditions studied: Breast Neoplasms
In brief
This multicenter trial using Hologic digital mammography units will evaluate the specificity of 2-D full field digital mammography (FFDM) versus a combination of 2-D and 3-D tomosynthesis imaging in breast cancer screening. Specificity, in this study, will be measured by the participant call-back rate by each modality. Varying combinations of 2-D mammography and tomosynthesis projections will be evaluated to optimize the screening paradigm and limit radiation exposure when tomosynthesis is incorporated. Both prospective and retrospective imaging data will be assessed. Hypothesis: Digital breast tomography (DBT) will improve the specificity of breast cancer screening as measured by a reduction in the call-back rate while maintaining the sensitivity of cancer detection. This improved accuracy will be achieved by the optimization of the imaging sequence and number of views obtained at a capped radiation dose in the combined DBT and 2-D screening sequence.
Key facts
- Study ID
- NCT01236781
- Run by
- American College of Radiology
- People needed
- 558
- Starts
- 2011-01-04
- Expected to finish
- 2013-12-31
- Last updated by the study team
- 2025-03-05
Who can join
Age: 25 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Women 25 years of age or older;
- No history of breast cancer;
- Group A only: Asymptomatic and scheduled for screening mammography;
- Group B only: Asymptomatic and recalled for diagnostic testing due to positive findings on recent screening using FFDM, completed within 30 days prior to registration (BI-RADS 0: additional imaging needed);
- Willing to provide a written informed consent.
You may not qualify if…
- Pregnancy or intent to become pregnant;
- Unable or unwilling to tolerate compression associated with mammography;
- Breast implants;
- Breasts too large to allow for adequate positioning for the DBT examination;
- Group B only: Patients with FFDM taken at screening who are unwilling or unable to submit images to ACRIN;
- Group B only: Unwilling to undergo tomosynthesis on both breasts as well as potentially additional diagnostic imaging based on tomosynthesis findings;
- Unable or unwilling to complete screening and (as necessary) diagnostic imaging at same facility;
- Tomosynthesis or mammography within 11 months prior to registration (excluding the screening mammography required for Group B).
Where it is running
- Hospital of University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Albery Einstein Medical Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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