September 2001

From University of North Carolina at Chapel Hill

New study to compare digital, film mammography in massive $26.5 million effort to save women’s lives

(Embargoed) CHAPEL HILL – Pictures may be worth a thousand words, but better pictures from the breast cancer screening technology known as mammography would be worth far more. Enhanced images could boost doctors’ ability to diagnose the deadly illness early and save countless lives.

In hope of cutting the toll from breast cancer among women in the United States and beyond, the National Cancer Institute has awarded a $26.5 million grant to a consortium of researchers at 19 institutions in the United States and Canada. Clinical scientists, statisticians, physicists and others will compare the new digital mammography to standard film mammography in a project eventually involving almost 50,000 women.

The grant will go to the American College of Radiology Imaging Network to fund a study titled the Digital Mammographic Imaging Screening Trial. Using computer and special detectors, digital mammography produces a digital image of the breast that can be displayed on high-resolution monitors.

“Standard mammography has been the most studied screening technology over the past 40 years, and so we know more about it than almost any other diagnostic technique in medicine,” said principal investigator Dr. Etta D. Pisano of the University of North Carolina at Chapel Hill.

“What we have is a well-proven technology and one that is in its infancy and not as well studied yet so we have to be very careful,” said Pisano, professor of radiology at the UNC School of Medicine and co-leader of the UNC Lineberger Comprehensive Cancer Center’s breast program. “Before it is widely used, we want to make sure that digital mammography is at least as good as standard mammography at finding early breast cancers.”

Digital mammography may reveal cancers in women with dense breast tissue better because of its improved contrast resolution, she said. Smaller previous studies also suggested it could reduce the number of women called back to check suspicious lesions.

“Although the equipment for digital mammography costs more, fewer callbacks and extra office visits could save money and lessen patients’ concerns,” Pisano said. “As part of this study, we also plan to study cost effectiveness and the impact of false positives on women’s quality of life.”

Dr. Daniel Sullivan, who is coordinating the trial for the National Cancer Institute, said digital mammography might detect breast cancer earlier. “But a large study is needed to really determine whether digital mammography is better than conventional mammography, and if it is better, how large the difference is,” Sullivan said.

Results of the trial, which is the cooperative research network’s most ambitious undertaking, will guide women’s breast care into the future, said Dr. Bruce J. Hillman, chair of the research network. “This work is very exciting, and it’s going to be very important,” said Pisano, chief of breast imaging at UNC Hospitals.

Beginning Monday, Oct. 15 at most sites and ending 18 months later, 49,500 symptom-free women will be recruited into the study during their regular screening mammograms, she said.

Patients will receive both conventional and digital mammography under nearly identical conditions and be followed for several years.

Others involved in the clinical research include co-principal investigator Dr. R. Edward Hendrick of Northwestern University, lead physicist Dr. Martin Yaffe of the University of Toronto and statistical coordinator Dr. Constantine Gatsonis of Brown University. Respectively, Drs. Dennis Fryback of the University of Wisconsin and Anna Tosteson of Dartmouth Medical School will direct the quality-of-life and cost-effectiveness analyses. Data coordination will take place at the American College of Radiology’s research network headquarters in Philadelphia.

UNC faculty most closely involved will be Drs. Cherie Kuzmiak, Marcia Koomen and Robert McLelland, all radiologists, and Dr. R. Eugene Johnston, a physicist. GE Medical Systems, Fuji Medical Systems, Fischer Imaging and LORAD digital mammography systems will be tested in the trial. The U.S. Food and Drug Administration approved the GE device in February, 2000, and the other two are pending approval. Widespread film mammography use dates to the early 1960s.

Participating institutions are the universities of California at Los Angeles and Davis, Massachusetts and Washington at Seattle, Memorial Sloan-Kettering Cancer Center, Georgetown University and others. A complete list is available at http://www.dmist.org. Women wishing to volunteer should contact the sites directly to learn how.

Note: Pisano is available at 919-966-6957, but she can respond to e-mail faster, etpisano@med.unc.edu.
News Services contacts: David Williamson, 962-8596, or Karen Moon, 962-8595











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