April 18, 2002
MEDIA CONTACT: Gary Stephenson
Hopkins Is One Site for International Study on Noninvasive Treatment of Uterine Fibroids
The Johns Hopkins Hospital is one of eight worldwide sites chosen to conduct a Phase 3 clinical trial on the treatment of uterine fibroids using magnetic resonance imaging (MRI)-guided high intensity focused ultrasound.
Fibroids are benign tumors that affect an estimated 40 percent of all women over 40, according to Hyun S. Kim, M.D., assistant professor of radiology and surgery and director of gynecologic intervention at Hopkins. They may can cause pain, heavy menstrual bleeding, incontinence, and in some cases, infertility. Traditional treatments, such as surgical removal of fibroids or hysterectomy, can require weeks of recovery.
For the study, Kim and his team will use real-time magnetic resonance imaging to identify the precise locations of the fibroids, and then deliver focused ultrasound wave energy through the abdominal wall. Within seconds, the technique is expected to heat the targeted tissue enough to damage or destroy fibroids. Over the following weeks, the dead tissue should be eliminated naturally from the body.
"The study has the potential to demonstrate the safety and effectiveness of an entirely new approach to treating uterine fibroid tumors," says Kim, "one that is much less traumatic to the patient."
Phase 2 trials in London and Boston already have demonstrated the safety of the treatment to treat symptomatic uterine fibroids. The Phase 3 study will also be conducted at Brigham and Women's Hospital in Boston, the Mayo Clinic in Rochester, Minn, Saint Mary's Hospital in London, the Charite Medical Center in Berlin, the Cochine Hospital in Paris, Sheba Medical Center in Tel Aviv and the Hadassah Hospital in Jerusalem.
Eligible study participants include women diagnosed with uterine fibroid tumors who are not breastfeeding, are able to undergo MRI, and who have completed their families. The single outpatient procedure takes three to four hours. Women interested in enrolling in the study or in obtaining more information should call 410-614-1622 or 410-614-4212.