Digital VS. Screen-Film Mammography
- 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
- 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.
Primary Purpose: Screening
Etta Pisano, MD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Lineberger Comprehensive Cancer Center, UNC||Chapel Hill, North Carolina 27599-7295|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Simmons Cancer Center - Dallas||Dallas, Texas 75235-9154|
|University of Washington Medical Center||Seattle, Washington 98195-6043|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|
|Mount Sinai School of Medicine||New York, New York 10029|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Cancer Center at the University of Virginia||Charlottesville, Virginia 22908|
|Roger Williams Medical Center/BUSM||Providence, Rhode Island 02908-4735|
|University of Colorado Cancer Center at University of Colorado Health Sciences Center||Denver, Colorado 80010|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Lahey Clinic - Burlington||Burlington, Massachusetts 01805|
|Allegheny General Hospital||Pittsburgh, Pennsylvania 15212-4772|
|William Beaumont Hospital||Royal Oak, Michigan 48073|
|Monmouth Medical Center||Long Branch, New Jersey 07740-6395|
|University of California Davis Cancer Center||Sacramento, California 95817|
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|
|Siteman Cancer Center||Saint Louis, Missouri 63110|
|La Grange Memorial Hospital||La Grange, Illinois 60525|
|Washington Radiology Associates, P.C.||Washington, District of Columbia 20037|
|Emory Health Care Clinic||Atlanta, Georgia 30322|
|Shore Memorial Hospital||Somers Point, New Jersey 08244|
|Elizabeth Wende Breast Clinic||Rochester, New York 14620|