OT2-05-04: ACRIN PA 4006: Comparison of Full-Field Digital Mammography with Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate.

Abstract

Abstract Background With competing parameters of specificity and sensitivity, breast cancer screening must limit both missed cancers and false-positive call-backs (with potential to biopsy) to reduce cost and unnecessary anxiety to patients. Full-field digital mammography (FFDM) has been shown to provide improved sensitivity over analog mammography in the detection of breast cancers, particularly in women with dense breasts. Unfortunately, call-back rates for both digital and analog screening mammography have similar, elevated rates of approximately 10% (E. Pisano et al, NEJM, 2005). Incorporation of digital breast tomosynthesis (DBT), a novel 3-D reconstruction of multiple low-dose digital mammographic images, may reduce the number of call-back visits needed by providing many of the benefits of diagnostic imaging at screening. This study will assess variations in DBT image acquisition while limiting radiation dose to women with varying breast sizes and densities, to define parameters to be used in a larger national screening tomosynthesis trial. Eligibility: Asymptomatic women 25 years and older with no breast cancer history are eligible for Group A or B (see below). Pregnant women, women unable to tolerate compression of the breast associated with mammography, women with implants, and women with breasts too large for DBT are excluded from participation. Trial design/target accrual: This multicenter trial uses Hologic digital mammography units at two institutions in Philadelphia, Pennsylvania. The timing of the study-related imaging visits are segregated into two cohorts, screening (Group A) and diagnostic (Group B). Group A comprises 500 women who will undergo both FFDM and DBT at screening. Initial independent interpretations of the FFDM and DBT from local readers will determine call back. Enriched Group B comprises 50 women who have been informed of abnormal findings from a FFDM screening within 30 days of enrollment. They will be recruited prior to their diagnostic imaging and consent to DBT of both breasts as part of their diagnostic imaging. Participants from both Groups will be followed or biopsied as recommended by their treating physician. Follow up includes medical record review and images collection at approximately 1-year. Follow-up data may be collected up to 18 months. Specific aims and statistical methods: ACRIN PA 4006 will evaluate the specificity of 2-D FFDM versus a combination of 2-D and 3-D tomosynthesis imaging in breast cancer screening. Specificity will be measured by the participant call-back rate by each modality. Sensitivity and specificity by lesion-type characteristics, especially focused on DBT assessment of calcifications, will be compared. Current accrual: Currently, the trial accrual has reached 259 of 550. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr OT2-05-04.