December 12, 1995
Web posted at: 9:00 a.m. EST
From Correspondent Eugenia Halsey
WASHINGTON (CNN) -- When a mammogram or self-examination reveals a lump in a woman's breast, doctors have to decide their next action. Up to 80 percent of the lumps eventually turn out not to be cancerous; yet each year, 800,000 women in the United States must undergo painful biopsies to get a diagnosis.
Now, a company based near Seattle, Washington -- Advanced
Technology Laboratories (ATL) -- has developed an ultra-sound
device known as "high definition imaging." HDI is designed to
help doctors determine whether a tumor is cancerous or non-
cancerous without performing a biopsy.
An FDA advisory panel has already voted unanimously in favor of recommending approval of the ultra-sound, although its use initially will be limited to tumors no smaller than one centimeter.
ATL's Gene Larson said that in a study conducted by the company, researchers determined that up to one-third of biopsies could be eliminated with the use of the HDI system. One thousand women in North America and Europe participated in the study for 18 months.
Dr. Christopher Merritt examined 100 of the women at the Ochsner Clinic in New Orleans, Louisiana, and found the ultra-sound very effective. The device, he said, did not miss any cancers.
"We feel this is an important step in the direction of better patient care," Merritt said, allowing doctors to "differentiate those patients that need the more invasive procedure ... from those that can be followed conservatively."
Dr. Susan Alpert, of the U.S. Food and Drug Administration, said that HDI also speeds up the diagnostic process.
"The determination is made fairly rapidly," she said. "You
don't have the concerns raised by a biopsy such as ...
anxiety on the part of the women waiting for results..."
ATL officials also say surgical biopsies can cost eight to ten times as much as the ultra-sound exam costs.
The FDA usually follows the advisory panel's recommendation. Advocates of using this high-definition ultra-sound to help diagnose breast cancer say it could make a significant contribution to women's health care.
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