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

American College of Radiology (ACR)

Status: Completed

Conditions: Breast Neoplasms

Treatments: Device: Diagnostic Tomosynthesis; Device: Screening Tomosynthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT01236781

ACRIN PA 4006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 558 patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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558 participants in 2 patient groups

Group A: Screening

Experimental group

Description:

Group A comprises 500 asymptomatic women with no history of breast cancer who are scheduled for routine screening of the breasts with FFDM.

Treatment:

Device: Screening Tomosynthesis

Group B: Diagnostic Enriched Population

Experimental group

Description:

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).

Treatment:

Device: Diagnostic Tomosynthesis