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

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ClinicalTrials.gov Identifier: NCT01236781
Recruitment Status : Unknown
Verified March 2012 by American College of Radiology Imaging Network.
Recruitment status was:  Active, not recruiting
First Posted : November 9, 2010
Last Update Posted : March 14, 2012
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
American College of Radiology Imaging Network

Tracking Information
First Submitted Date  ICMJE November 5, 2010
First Posted Date  ICMJE November 9, 2010
Last Update Posted Date March 14, 2012
Study Start Date  ICMJE December 2010
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2010)
Primary Aim: Recall Rates [ Time Frame: 1 year ]
To compare recall rates of FFDM to the limited DBT set (digital breast two-view tomosynthesis with low-dose MLO) [Group A].
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2010)
  • Secondary Aim: Sensitivity [ Time Frame: 1 year ]
    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 ]
    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 ]
    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 ]
    To calculate and compare the radiation dose of the FFDM and the DBT sets.
  • Secondary Aim: Radiation Dose and Quality [ Time Frame: 1 year ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates
Official Title  ICMJE Comparison of Full-Field Digital Mammography With Digital Breast Tomosynthesis Image Acquisition in Relation to Screening Call-Back Rate
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Screening Tomosynthesis
  • 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).
    Intervention: Device: Diagnostic Tomosynthesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2010)
550
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01236781
Other Study ID Numbers  ICMJE ACRIN PA 4006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party American College of Radiology Imaging Network
Study Sponsor  ICMJE American College of Radiology Imaging Network
Collaborators  ICMJE Pennsylvania Department of Health
Investigators  ICMJE
Study Chair: Emily F. Conant, MD Hospital of University of Pennsylvania
PRS Account American College of Radiology Imaging Network
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP