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

NCT01236781 | Completed Results DMC

• 1 other identifier: ACRIN PA 4006
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Neoplasms

Keywords

breast cancer; screening; diagnostics; diagnosis; high-risk; breast neoplasms; digital mammography; mammography; tomosynthesis; dense breasts; radiation dose; comparison; Hologic; Pennsylvania; Philadelphia; breast study; mammo; tomo; mammary

Outcome Measures

Primary Outcomes (1)

• Recall Rate in Group A Participants

  Each participant will undergo both FFDM and DBT examinations. Each of the two exams will be interpreted separately by readers at the participating sites and any positive finding for diagnostic followup will be considered a recall.

  at the first imaging session

Secondary Outcomes (6)

• Accuracy Based on Pathology Results

  at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome)

• Accuracy, Based on Pathology Results, by Lesion Classification

  at the first imaging session, at the Diagnostic workup (within 30 Days after Screening), and 1 year (pathologic outcome)

• Callback Rate of Two-view Limited Tomosynthesis Set (With Low-dose MLO View Alone) With the Tomosynthesis Plus Set (Low-dose MLO View Plus Addition of Low-dose CC View)

  At the Diagnostic workup (within 30 Days After Screening) and up to 18-months post-screening (Pathology Measure)

• Radiation Dose

  at the first imaging session

• Regression Model Parameters for Factors Effecting Radiation Dose

  at the first imaging session

Study Arms (2)

Group A: Screening

EXPERIMENTAL

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

Device: Screening Tomosynthesis

Group B: Diagnostic Enriched Population

EXPERIMENTAL

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).

Device: Diagnostic Tomosynthesis

Interventions

Screening Tomosynthesis DEVICE

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

Also known as: Hologic, Dimension

Group A: Screening

Diagnostic Tomosynthesis DEVICE

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

Also known as: Hologic, Dimension

Group B: Diagnostic Enriched Population

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• American College of Radiology: lead
• Pennsylvania Department of Health: collaborator

Study Sites (2)

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19118, United States

Location

Albery Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (2)

• 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.

  PMID: 27236612 BACKGROUND

• 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.

  PMID: 27002418 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Disease

Interventions

Vertical Dimension

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Occlusion, Centric; Dental Occlusion; Dentistry

Results Point of Contact

• Title: Director Clinical Research Administration
• Organization: American College of Radiology

info@acr.org

215-574-3150

Study Officials

• Emily F. Conant, MD

  Hospital of University of Pennsylvania

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 9, 2010
• Study Start: January 4, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 31, 2013
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Locations

US (2)