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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by American College of Radiology Imaging Network.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT01236781
First received: November 5, 2010
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Device: Screening Tomosynthesis
Device: Diagnostic Tomosynthesis
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • Primary Aim: Recall Rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To compare recall rates of FFDM to the limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) [Group A].


Secondary Outcome Measures:
  • Secondary Aim: Sensitivity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To compare sensitivity of FFDM to the limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) [Groups A and B].

  • Secondary Aim: Lesion-Type Characterization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    1. To compare the sensitivity and specificity by lesion-type characterization (calcification-only lesions versus soft-tissue lesions, as well as lesion subgroups: masses, calcifications, architectural distortions, asymmetries) in FFDM versus DBT (two-view tomosynthesis set with low-dose MLO) [Group A call-back cohort and Group B];
    2. To estimate the agreement of FFDM and DBT with the determination of the adjudication committee on lesion-type characterization.

  • Secondary Aim: Comparison of Views [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    To use the sequential interpretation results [Groups A and B] in order to compare the 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) on the basis of:

    • Call-back rate;
    • Identification of new lesion(s);
    • Lesion characterization; and
    • Triangulation.

  • Secondary Aim: Radiation Dose [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    To calculate and compare the radiation dose of the FFDM and the DBT sets.

  • Secondary Aim: Radiation Dose and Quality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    To identify the determinants of participant radiation dose and clinical image quality, including factors such as kVp, mAs, target/filter combination, and breast thickness and composition.


Estimated Enrollment: 550
Study Start Date: December 2010
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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).
Other Names:
  • Hologic
  • Dimension
Experimental: 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).
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).
Other Names:
  • Hologic
  • Dimension

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236781

Locations
United States, Pennsylvania
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19118
Albery Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
American College of Radiology Imaging Network
Pennsylvania Department of Health
Investigators
Study Chair: Emily F. Conant, MD Hospital of University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT01236781     History of Changes
Other Study ID Numbers: ACRIN PA 4006
Study First Received: November 5, 2010
Last Updated: March 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by American College of Radiology Imaging Network:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014