Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates

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.

Sex

Female

Minimum age

25 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

• BACKGROUNDRay S, Chen L, Keller BM, Chen J, Conant EF, Kontos D. Association between Breast Parenchymal Complexity and False-Positive Recall From Digital Mammography Versus Breast Tomosynthesis: Preliminary Investigation in the ACRIN PA 4006 Trial. Acad Radiol. 2016 Aug;23(8):977-86. doi: 10.1016/j.acra.2016.02.019. Epub 2016 May 25. PMID 27236612
• RESULTChen L, Ray S, Keller BM, Pertuz S, McDonald ES, Conant EF, Kontos D. The Impact of Acquisition Dose on Quantitative Breast Density Estimation with Digital Mammography: Results from ACRIN PA 4006. Radiology. 2016 Sep;280(3):693-700. doi: 10.1148/radiol.2016151749. Epub 2016 Mar 22. PMID 27002418