|Digital Mammography Trial Results Announced:
Women with Dense Breasts, Women Younger than 50, and Those Who are Perimenopausal
May Benefit from Digital Mammograms
Preliminary results from a large, clinical trial of digital vs.
film mammography show no difference in detecting breast cancer
for the general population of women
in the trial. However, those women with dense breasts, who are
pre- or perimenopausal (women who had a last menstrual period within
12 months of their mammograms),
or who are younger than age 50 may benefit from having a digital
rather than a film mammogram. The results were reported September
16, 2005 in a special online
publication of the New England Journal of Medicine* and
at a meeting of the American College of Radiology Imaging Network
(ACRIN) in Pentagon City, Virginia.
The trial, sponsored by the National Cancer Institute (NCI), part of the National
Institutes of Health, was conducted by a network of researchers led by ACRIN. "These
results will give clinicians better guidance and greater choice in deciding which
women would benefit most from various forms of mammography," said senior author,
Etta Pisano, M.D., University of North Carolina at Chapel Hill.
Secondary goals measuring the relative cost-effectiveness of both digital and
film technologies, and the effect on participant quality of life due to the expected
reduction of false positives, are still being assessed and will be reported at
a later date.
“This digital mammography study demonstrates how new technologies are expanding
our ability to detect breast cancer earlier in more women. The study corroborates
NCI’s commitment to exploring advanced technologies in a wide range of clinical
applications and the critical role they can play in making cancer a manageable
disease,” said NCI Director Andrew C. von Eschenbach, M.D.
Starting in October 2001, the Digital Mammographic Imaging Screening Trial (DMIST)
enrolled 49,528 women who had no signs of breast cancer at 33 sites in the United
States and Canada. Women in the trial were given both digital and film examinations.
Examinations were interpreted independently by two different radiologists. Breast
cancer status was determined through available breast biopsy information within
15 months of study entry or through follow-up mammography ten months or later
after study entry.
Digital mammography takes an electronic image of the breast and stores it directly
in a computer, allowing the recorded data to be enhanced, magnified, or manipulated
for further evaluation. The electronic image also can be printed on film. Film
mammography units use film to both capture and display the image. The sensitivity
of film mammography is somewhat limited in women with dense breasts, a population
at higher risk for breast cancer.
General Electric Medical Systems, Fuji Medical Systems, Fischer Imaging, and
Hologic digital mammography systems were tested in the trial. Of these, all except
for the Fuji system are already approved by the U.S. Food and Drug Administration
and are available for clinical use in the United States.
An estimated 211,240 women will be diagnosed with breast cancer in the U.S.
this year, making it the most commonly diagnosed cancer in women. An estimated
40,410 women will die of the disease this year in the United States.
For a Q&A on this study, go to http://www.nci.nih.gov/newscenter/pressreleases/DMISTQandA.
For more information about the Digital Mammographic Imaging Screening Trial
(DMIST), please go to the DMIST Web site at http://www.cancer.gov/dmist.
For more information about cancer, visit the NCI Web site at http://www.cancer.gov or
call NCI's Cancer Information Service at 1-800-4 CANCER (1-800-422-6237).
The National Institutes of Health (NIH) — The Nation's Medical Research
Agency — includes 27 Institutes and Centers and is a component of
the U. S. Department of Health and Human Services. It is the primary Federal
agency for conducting and supporting basic, clinical, and translational medical
research, and investigates the causes, treatments, and cures for both common
and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.