This trial is active, not recruiting.

Condition breast neoplasms
Treatments screening tomosynthesis, diagnostic tomosynthesis
Phase phase 2/phase 3
Sponsor American College of Radiology Imaging Network
Collaborator Pennsylvania Department of Health
Start date December 2010
End date June 2012
Trial size 550 participants
Trial identifier NCT01236781, ACRIN PA 4006


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose screening
Group A comprises 500 asymptomatic women with no history of breast cancer who are scheduled for routine screening of the breasts with FFDM.
screening tomosynthesis Hologic
Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).
Approximately 50 asymptomatic women with no history of breast cancer who have been informed of positive (abnormal) findings from a recent (within 30 days) FFDM screening will be recruited to Group B prior to their diagnostic imaging (e.g., diagnostic FFDM and/or ultrasound and/or other).
diagnostic tomosynthesis Hologic
Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).

Primary Outcomes

Primary Aim: Recall Rates
time frame: 1 year

Secondary Outcomes

Secondary Aim: Sensitivity
time frame: 1 year
Secondary Aim: Lesion-Type Characterization
time frame: 1 year
Secondary Aim: Comparison of Views
time frame: 1 year
Secondary Aim: Radiation Dose
time frame: 1 year
Secondary Aim: Radiation Dose and Quality
time frame: 1 year

Eligibility Criteria

Female participants at least 25 years old.

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).

Additional Information

Official title Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate
Description Asymptomatic women 25 years and older with no history of breast cancer will be recruited from a prospective population of patients scheduled for screening mammography (Group A). A similar population of women called back from screening for 2-D FFDM-detected abnormalities will also be recruited to provide an enriched population of true-positive and false-positive 2-D FFDM and tomosynthesis cases (Group B). Pregnant women, women unable to tolerate compression of the breast associated with mammography, women with implants, and women with breasts too large to accommodate adequate positioning of the breast for DBT are excluded from trial participation. A total of 550 participants will be recruited--500 women will enroll for collection of prospective imaging data in this trial (Group A); 50 additional participants, recalled for diagnostic assessment after positive screening findings, will be recruited for DBT imaging data collection and retrospective image analysis (Group B). Participating institutions for this trial will be clinical research institutions in Pennsylvania with Hologic tomosynthesis units.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by American College of Radiology Imaging Network.