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Digital Mammography Screening Trial (ACRIN6652) (DMIST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00008346
First Posted: January 27, 2003
Last Update Posted: July 11, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
American College of Radiology Imaging Network
  Purpose

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.


Condition Intervention
Breast Cancer Diagnostic Test: Full Field Digital Mammography Diagnostic Test: Screen Film Mammography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women

Resource links provided by NLM:


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

Enrollment: 49528
Actual Study Start Date: October 2001
Study Completion Date: June 30, 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008346


  Show 32 Study Locations
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Investigators
Study Chair: Etta Pisano, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Publications:

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT00008346     History of Changes
Other Study ID Numbers: CDR0000068399
ACRIN-6652 ( Other Identifier: American College of Radiology )
U01CA080098 ( U.S. NIH Grant/Contract )
U01CA079778 ( U.S. NIH Grant/Contract )
First Submitted: January 6, 2001
First Posted: January 27, 2003
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by American College of Radiology Imaging Network:
breast cancer

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