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By Peggy Peck

CHICAGO (Reuters Health) – Results of a pilot study of MRI-guided focused ultrasound surgery (FUS) for leiomyoma of the uterus suggest that the investigational procedure is safe and effective, said Dr. Clare Tempany of Harvard Medical School.

Dr. Tempany said FUS "melted away" fibroids in nine patients who underwent the procedure at Brigham and Women's Hospital, Boston. She presented the study here at the 87th Scientific Assembly and Annual Meeting of the Radiological Society of North America.

In an interview with Reuters Health, Dr. Tempany said that all women in the pilot study went on to hysterectomy, "so we have pathological results to demonstrate that FUS caused necrosis in the fibroids." Early next year she will begin enrolling "20 to 30 women with symptomatic fibroids in a study of FUS as definitive treatment," she said.

Centers in Britain and Israel are also studying FUS for uterine fibroids, so a total of 28 women have undergone FUS treatment, Dr. Tempany explained. She said the treatment is very well tolerated. "One or two women have experienced some uterine cramping, two had skin blisters and one reported some bleeding." But most women come to the hospital "in the morning, lie on a table for 4 hours of treatment, and after that they get up and go home to resume normal lives."

She said FUS technology has been available since 1962 but "we needed MR guidance to make it practical. This is a perfect fit of two technologies." The FUS system is placed "inside the magnet," which acts like a magnifying glass to focus the ultrasound rays on the fibroid. Those rays "heat up the tissue, which cuts off the blood supply and causes the fibroid to necrose."

On pathologic examination the area of necrosis "exceeds the treatment area, which suggests that cutting off the blood supply in one area extends the therapeutic benefit," Dr. Tempany said.

She said FUS treatment is probably impractical for women with "15 to 20 fibroids, because the time to treat would be prohibitive." In her study women had one to five fibroids and treatment time averaged 4 hours. But Dr. Tempany added that eliminating symptoms "only requires treating the [specific] fibroid that causes bleeding or pain." As the technology develops, she predicted, it will be possible to pinpoint the symptomatic fibroid.

Her protocol requires that a radiologist be present "throughout the treatment," which makes it labor-intensive, but she estimated that it costs "only a couple of thousand dollars, which is less than surgery."

Dr. Tempany said her group is also studying FUS in breast cancer and next year plans a study of FUS for treatment of neurofibromatosis.

Insightec-TxSonics in Dallas, Texas, the maker of the FUS device, funded the study.