THE VIRGINIAN-PILOT
Copyright (c) 1996, Landmark Communications, Inc.
DATE: Saturday, April 13, 1996 TAG: 9604130361
SECTION: FRONT PAGE: A3 EDITION: FINAL
SOURCE: THE WASHINGTON POST
DATELINE: WASHINGTON LENGTH: Medium: 63 lines
The Food and Drug Administration approved the use of ultrasound equipment Friday to help determine whether lumps in women's breasts are cancerous.
The diagnostic procedure could eventually help hundreds of thousands of women each year avoid biopsies.
The FDA approved an application by Advanced Technology Laboratories of Bothell, Wash., to use its high-definition imaging equipment, now on the market for other uses, in breast cancer diagnosis. About 700,000 women undergo biopsy each year to determine the nature of suspicious lumps in their breasts, and the FDA said the ultrasound technique could reduce the number of such surgeries by as much as 40 percent.
In December 1995, an FDA advisory panel recommended approval of the devices for that use. Friday's action by the FDA allows the company to promote its devices for the newly approved use on women with breast lumps 3/8 of an inch or larger.
In ultrasound - used, for example to get a diagnostic peek at fetuses during pregnancy - a machine sends high-frequency sound waves through the body's tissues and builds an image from the echoes. Researchers have been able to use conventional ultrasound for some time to predict whether the lumps were solid or cystic - that is, filled with fluid and likely to be benign.
The higher-definition machines from Advanced Technology Laboratories give an image sharp enough to allow doctors to distinguish between benign and cancerous lumps.
Dick Tabbutt, director of outcomes research for the company, said Friday that doctors using the technique examine the border of the lump. If the margin ``is very irregular and angulated, and looks like it's invading the surrounding tissue, that is an ominous sign'' and a biopsy should be ordered. If the border of the lump appears smooth, among other factors, the lump is almost certainly benign.
In clinical studies presented to the FDA, the firm examined 1,270 women with 1,344 breast lumps detected by mammography or by physical examination. Doctors were unsure whether 431 of the solid lumps were benign or malignant.
In the study, the researchers predicted 176 of those lumps were benign. All of the women in the study had biopsies, and those procedures confirmed the 176 lumps predicted to be benign were indeed noncancerous.
Both mammography and the ultrasound had predicted one lump in the larger study to be benign that in fact contained a tiny cancerous lump.
``What we would like to see is this use of ultrasound to become a standard of care,'' Tabbutt said, who added that his company is training doctors to use the device.
The technique could allow many women to avoid the trouble and expense of biopsy, said Dan Schultz, an FDA medical officer and surgeon.
The current rate of false positives for mammography is about 75 percent. Of 700,000 breast biopsies done on lumps each year - in almost all cases, after a mammogram has suggested a possible cancer - about 180,000 cancers are found. The new technique could help bring down that false positive rate to about 41 percent, Tabbutt said.
KEYWORDS: FDA BREAST CANCER by CNB