Focused US treats fibroids in phase II study. (Successful in 43 of 55 Women).

NEW YORK--Focused ultrasound guided by MRI accurately treated 43 of 55 women with uterine fibroids in a multi-center phase II study prompting initiation of a phase III clinical trial.

This procedure may provide a less painful and less invasive treatment option for fibroids, compared with uterine artery embolization or hysterectomy, Dr. Elizabeth A. Stewart said at the 12th World. Congress on Ultrasound in Obstetrics and Gynecology.

With high-intensity focused ultrasound, the ultrasound is focused to deliver thermal energy in excess of 550 C to a point inside the body destroying tissue or cauterizing a lesion or blood vessel, usually without damaging surrounding tissue.

Study participants were premenopausal women who were scheduled for hysterectomy to treat intramural fibroids so that pathology findings could be correlated with focused ultrasound treatments. The women underwent a pretreatment physical exam and MRI of their fibroids, followed by a second visit for MRI-guided focused ultrasound therapy under conscious sedation with continuous monitoring.

Each patient spent up to 4 hours in the MRI scanner, including 2 hours of active treatment, and returned within 72 hours for a follow-up visit. They will be assessed at 1, 3, and 6 months post treatment, said Dr. Stewart, a paid consultant for InSightec Ltd., which makes focused ultrasound equipment and funded the study.

A test sonication and temperature mapping were to be performed on each patient to make sure the ultrasound targeted the right tissue at the right temperature. Two patients did not undergo sonication, one because of equipment failure and the other because the bowel could not be moved out of the way of the uterus.

The treatment was considered suboptimal in another 10 patients, usually because the test sonication ...