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

NCT ID: NCT01236781

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-04
• Study Completion Date: 2013-12-31

Brief Summary

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.

Detailed 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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Group A: Screening

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

Group Type: EXPERIMENTAL

Screening Tomosynthesis

Intervention Type: DEVICE

Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).

Group B: Diagnostic Enriched Population

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).

Group Type: EXPERIMENTAL

Diagnostic Tomosynthesis

Intervention Type: DEVICE

Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).

Interventions

Screening Tomosynthesis

Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).

Intervention Type: DEVICE

Diagnostic Tomosynthesis

Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).

Intervention Type: DEVICE

Other Intervention Names

Hologic; Dimension; Hologic; Dimension

Eligibility Criteria

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).

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pennsylvania Department of Health

OTHER_GOV

Sponsor Role: collaborator

American College of Radiology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily F. Conant, MD

Role: STUDY_CHAIR

Hospital of University of Pennsylvania

Locations

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, United States

Albery Einstein Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

Ray 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.

Reference Type: BACKGROUND

PMID: 27236612 (View on PubMed)

Chen 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.

Reference Type: RESULT

PMID: 27002418 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ACRIN PA 4006

Identifier Type: -

Identifier Source: org_study_id