Digital Mammography Screening Trial (ACRIN6652) (DMIST)

July 7, 2017 updated by: American College of Radiology Imaging Network

Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. It is not yet known which type of mammography is more effective in detecting breast cancer.

PURPOSE: Screening and diagnostic trial to compare the effectiveness of two types of mammography in detecting breast cancer in women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the diagnostic performance of digital mammography vs screen-film mammography, as measured by the area under the Receiver Operating Characteristic (ROC) curve, sensitivity, specificity, and positive and negative predictive values, in the detection of breast cancer in women.
  • Compare the diagnostic accuracy of the digital mammogram obtained using each of the individual manufacturer's digital units vs screen-film mammography through retrospective reader studies.
  • Determine the effects of patient characteristics, including age, lesion type, pathologic diagnosis, menopausal and hormonal status, breast density, and family history, on diagnostic accuracy of digital mammography.
  • Determine the effects of technical parameters, including display type, machine type, and detector spatial and contrast resolution, on diagnostic accuracy of digital mammography.
  • Determine the effect of reduced false-positive mammograms that are expected with digital mammography on the health-related quality of life and personal anxiety of women undergoing this screening experience.
  • Compare the diagnostic performance of digital mammography with the rate of cancer in a set of cases through a retrospective reader study.
  • Compare the effect of softcopy vs printed film display on the diagnostic performance of digital mammography through a retrospective reader study.
  • Compare the effect of breast density on the diagnostic accuracy of digital mammography vs screen-film mammography through a retrospective reader study.
  • Compare the image quality and breast radiation dose in digital vs screen-film mammography in these participants.
  • Determine the temporal variations in image quality, breast radiation dose, and other quality control parameters in the participating study centers.

OUTLINE: This is a randomized, multicenter study. Participants with postitive screening results are stratified according to age (under 50 vs 50-59 vs 60-70 vs over 70). Participants are randomized to one of two treatment arms.

  • Arm I: Participants undergo a two-view screen-film mammogram followed by a two-view digital mammogram of each breast.
  • Arm II: Participants undergo a two-view digital mammogram followed by a two-view screen-film mammogram of each breast.

Quality of life is assessed before the screening mammogram in the first 800 women enrolled. In an additional 1,200 participants (600 with positive screening results and 600 with negative screening results), quality of life is assessed shortly after the screening mammogram and at 1 year.

Participants are followed at 1 year with a repeat screen-film or digital mammogram.

PROJECTED ACCRUAL: A total of 49,500 participants (24,750 per arm) will be accrued for this study within 18 months.

Study Type

Interventional

Enrollment (Actual)

49528

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • North York, Ontario, Canada, M4N 3M5
        • Sunnybrook and Women's College Health Sciences Centre
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Jonsson Comprehensive Cancer Center, UCLA
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20037
        • Washington Radiology Associates, P.C.
    • Florida
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Health Care Clinic
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60610
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      • La Grange, Illinois, United States, 60525
        • La Grange Memorial Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic - Burlington
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Siteman Cancer Center
    • New Jersey
      • Long Branch, New Jersey, United States, 07740-6395
        • Monmouth Medical Center
      • Somers Point, New Jersey, United States, 08244
        • Shore Memorial Hospital
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • New York, New York, United States, 10029-6574
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10003
        • Memorial Sloan-Kettering Cancer Center
      • Rochester, New York, United States, 14620
        • Elizabeth Wende Breast Clinic
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Lineberger Comprehensive Cancer Center, UNC
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0772
        • Charles M. Barrett Cancer Center at University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of The University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15212-4772
        • Allegheny General Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02908-4735
        • Roger Williams Medical Center/BUSM
    • Texas
      • Dallas, Texas, United States, 75390-8585
        • Simmons Cancer Center - Dallas
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Cancer Center at the University of Virginia
    • Washington
      • Seattle, Washington, United States, 98112
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

4.1 Inclusion Criteria 4.1.1 All consecutive women presenting for screening mammography at the participating institutions will be eligible.

4.1.2 Signed study-specific informed consent. See Appendix I. 4.2 Exclusion Criteria 4.2.1 All women who have presented with a complaint of a focal dominant lump or a bloody or clear nipple discharge.

4.2.2 All women who have breast implants. 4.2.3 Any woman who is pregnant or has reason to believe that she might be pregnant.

4.2.4 Participants who cannot, for any reason, undergo follow-up screen-film mammography at the participating institution or provide mammograms from another institution for review for one year after study entry.

4.2.5 All women with a history of breast cancer treated with lumpectomy. Note: Women with a history of breast cancer treated with mastectomy who have now returned to a screening population will still be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: SFM then FFDM
Screen Film Mammography (SFM) followed by Full Field Digital Mammography (FFDM)
Diagnostic test: Full Field Digital Mammography
Radiologic test to screen women for Breast cancer using digital detectors
Other Names:
  • FFDM
  • Digital Mammography
Diagnostic test: Screen Film Mammography
Radiologic test to screen women for Breast cancer using plain film detectors a resolution screen
Other Names:
  • SFM
  • Plain Film Mamography
Other: FFDM then SFM
Full Field Digital Mammography (FFDM) followed by Screen Film Mammography (SFM)
Diagnostic test: Full Field Digital Mammography
Radiologic test to screen women for Breast cancer using digital detectors
Other Names:
  • FFDM
  • Digital Mammography
Diagnostic test: Screen Film Mammography
Radiologic test to screen women for Breast cancer using plain film detectors a resolution screen
Other Names:
  • SFM
  • Plain Film Mamography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American College of Radiology Imaging Network

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Etta Pisano, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2001

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

June 30, 2005

Study Registration Dates

First Submitted

January 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 7, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068399
  • U01CA080098 (U.S. NIH Grant/Contract)
  • U01CA079778 (U.S. NIH Grant/Contract)
  • ACRIN-6652 (Other Identifier: American College of Radiology)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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