Ultrasound Breast Cancer Test Approved
The Food and Drug Administration approved a powerful ultrasound device Friday to help doctors determine when lumps in women’s breasts are noncancerous, so those women can skip a common surgical cancer test.
Advanced Technology Laboratories predicts that its High-Definition Imaging, or HDI, ultrasound eventually will reduce by 40% the 700,000 breast biopsies performed annually in the United States.
From those biopsies, 180,000 cases of breast cancer are diagnosed every year. The rest of the cases are benign.
Women must have regular mammograms to detect any suspicious cells in their breasts. The ultrasound is intended to help doctors then decide which of those women need a biopsy.
A biopsy costs about $2,500, while the 15-minute, painless ultrasound test will cost $75 to $300, Seattle-based ATL said.
“No test is 100%, although this is very close,” said Dr. Brian Garra, a breast cancer specialist at Georgetown University Medical Center who advised the FDA on the machine’s effectiveness.
But “it doesn’t mean a clean bill of health,” he warned, noting that women who probably have benign lumps still must be watched to ensure that the mass doesn’t change, which can signal cancer.
A mammogram displays suspicious masses in breasts as blurry white spots against normal tissue.
Doctors can sometimes tell from a clear mammogram that the lesion is merely a cyst and may tell the woman just to get rechecked in a few months.
However, many doctors, to be safe, order a biopsy, cutting out a tiny portion of breast tissue to check for cancerous cells. But doctors want to reduce the number of unnecessary biopsies performed each year to spare women anxiety, pain and expense.
The ultrasound device sends high-frequency sound waves into the body that reflect back to create images. While weaker ultrasound is used in numerous medical procedures, ATL’s is the first strong enough to show a clear picture of breast lumps. If the lumps have, for example, smooth edges and no irregular colors or dark shadows, they probably are benign, ATL says.
The device cannot picture the very smallest lesions, so FDA scientists recommended it be used on those at least 0.4 inches wide.
Nine hospitals in eight states--California, Texas, Pennsylvania, Alabama, Illinois, Ohio, Louisiana and Connecticut--already have trained doctors to use the ultrasound device and can offer it immediately.
ATL is performing FDA-required training for other doctors and expects the machine to be in use nationwide by the end of the year.
