Digital Mammography Screening Trial (ACRIN6652)
- Conditions
- Breast Cancer
- Interventions
- Diagnostic Test: Full Field Digital MammographyDiagnostic Test: Screen Film Mammography
- Registration Number
- NCT00008346
- Lead Sponsor
- American College of Radiology Imaging Network
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 49528
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SFM then FFDM Full Field Digital Mammography Screen Film Mammography (SFM) followed by Full Field Digital Mammography (FFDM) FFDM then SFM Full Field Digital Mammography Full Field Digital Mammography (FFDM) followed by Screen Film Mammography (SFM) SFM then FFDM Screen Film Mammography Screen Film Mammography (SFM) followed by Full Field Digital Mammography (FFDM) FFDM then SFM Screen Film Mammography Full Field Digital Mammography (FFDM) followed by Screen Film Mammography (SFM)
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Emory Health Care Clinic
🇺🇸Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
La Grange Memorial Hospital
🇺🇸La Grange, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Lahey Clinic - Burlington
🇺🇸Burlington, Massachusetts, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Shore Memorial Hospital
🇺🇸Somers Point, New Jersey, United States
Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Elizabeth Wende Breast Clinic
🇺🇸Rochester, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Roger Williams Medical Center/BUSM
🇺🇸Providence, Rhode Island, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Sunnybrook and Women's College Health Sciences Centre
🇨🇦North York, Ontario, Canada
Washington Radiology Associates, P.C.
🇺🇸Washington, D.C., District of Columbia, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States