UT Southwestern Medical Center at Dallas has joined a nationwide trial to compare the effectiveness of digital mammography with screen-film mammography in detecting breast cancer.
The goal of the trial, sponsored by the American College of Radiology Imaging Network, is to record and compare digital with film mammograms from 49,500 women. Dr. Phil Evans, who leads the breast-imaging program at the Southwestern Center for Breast Care, is heading up the trial at UT Southwestern, which seeks to screen 2,475 women by April 2004.
"We're trying to determine whether digital mammography can be better than screen-film mammography at detecting breast cancer," said Evans, professor of radiology. "This is the first trial of digital mammography to include all the latest equipment and involve 29 mammography facilities nationwide."
The first digital mammography equipment was introduced in 1998 and approved by the Food and Drug Administration for clinical use in February 2000. Other systems have since been developed and have received FDA approval.
Although multiple systems are FDA-approved, Evans said the trials to obtain those approvals showed only that each company's technology was equivalent to screen-film mammography in breast-cancer detection. Both types provide black-and-white images of the breasts, and the equipment that obtains the images is almost identical in appearance. But the digital images are reviewed on high-resolution computer monitors rather than on X-ray films.
An important study question is whether digital's technical advantages can help doctors detect more cancers. If so, a broad shift from screen-film to digital would be warranted. If not, facilities that offer mammograms could continue to use existing screen-film equipment without worrying about sacrificing quality of care.
Each patient screened in the UT Southwestern trial will undergo a film mammogram and a digital mammogram. One radiologist will examine the digital image, and another will examine the film. The radiologists' reports will be recorded separately for purposes of the trial, but follow-up imaging exams will be ordered if a possible abnormality is detected on either exam.
Women coming to the Southwestern Center for Breast Care for screening mammograms can apply to join the trial. To be eligible, participants must: --Exhibit no symptoms associated with breast cancer;--Have no history of breast cancer treated with lumpectomy;--Have not undergone breast augmentation;--Not be pregnant;--Fill out a study-specific informed consent form;--Undergo a follow-up screen-film mammography at UT Southwestern or provide screen-film mammograms from another institution for review one year after entering the study.
The Southwestern Center for Breast Care's digital mammography system was installed in August 2002, and the physicians and staff went through an intensive training program to learn not only how to capture the X-ray images in digital format, but also how to use the integrated system where the images are stored and retrieved for reading.
For more information about joining the study, please contact Janna Brown at 214-648-5161.
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