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Digital Mammography Screening Trial (ACRIN6652) (DMIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00008346
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
American College of Radiology Imaging Network

Tracking Information
First Submitted Date  ICMJE January 6, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date July 11, 2017
Actual Study Start Date  ICMJE October 2001
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Digital Mammography Screening Trial (ACRIN6652)
Official Title  ICMJE Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • SFM then FFDM
    Screen Film Mammography (SFM) followed by Full Field Digital Mammography (FFDM)
    Interventions:
    • Diagnostic Test: Full Field Digital Mammography
    • Diagnostic Test: Screen Film Mammography
  • FFDM then SFM
    Full Field Digital Mammography (FFDM) followed by Screen Film Mammography (SFM)
    Interventions:
    • Diagnostic Test: Full Field Digital Mammography
    • Diagnostic Test: Screen Film Mammography
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July¬†7,¬†2017)
49528
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 30, 2005
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 120 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00008346
Other Study ID Numbers  ICMJE CDR0000068399
ACRIN-6652 ( Other Identifier: American College of Radiology )
U01CA080098 ( U.S. NIH Grant/Contract )
U01CA079778 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
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 National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Etta Pisano, MD UNC Lineberger Comprehensive Cancer Center
PRS Account American College of Radiology Imaging Network
Verification Date July 2017

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