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Summary of MR-Guided Focused Ultrasound Research Study

MRgFUS Table & MRI MachineMR Guided Focused Ultrasound (MRgFUS, also known as High Intensity Focused Ultrasound, or HIFU) is a promising new non-invasive, outpatient procedure for the treatment of uterine fibroids. During the procedure, high doses of focused sound waves heat and kill the fibroids without damaging the surrounding tissue. The procedure is performed in a Magnetic Resonance Imaging (MRI) scanner. The physician uses the MRI to pinpoint, guide, and continuously monitor the treatment.

Imagine using a magnifying glass to focus the sun's energy on a single point to create a flame to burn aleaf. If you hold yourhand very near the magnifying glass, very little, if any, heat is felt. If, however, you put your hand directly uner the small light focus created by the magnifying glass, it can burn. In much the same way, during MRgFUS the focused sound wave energy is directed at a small volume of the fibroid, raising its temperature high enough to cause thermal ablation (killing of the cells) without impacting surrounding tissues. Pulses of energy are repeated in different areas until the entire fibroid is treated.

Dr. Fischer was one of the primary investigators in a FDA trial to evaluate the new Sonalleve MRgFUS system developed by Philips Medical Systems to treat uterine fibroids. CHI Baylor St Luke's Hospital was the first institution in the United States to receive and begin research with this new device. Since delivery of the initial device in 2008, our team has performed some of the early research with the new MRgFUS machine, including collaborating with other investigators here in the US and in Europe on early safety studies and some of this initial research has been published in the medical literature. MRgFUS is a very promising new therapy that is designed to kill uterine fibroids by heating them with sound wave energy. It uses an MRI machine to guide and monitor the therapy. It does not require anything other than an IV and bladder catheter be inserted into your body. Results of early trials are promising for treating symptoms related to uterine fibroids. Potential advantages of this therapy are the very short recovery time, usually only 1 or 2 days and the potential to maintain fertility. Serious side effects are rare but include skin burns and heat damage to pelvic nerves.

Dr. Fischer, his research team at CHI Baylor St. Luke's and other co-investigators in the US and worldwide were part of a pivotal trial for the Philips Sonalleve MRgFUS unit. This was the first time this system was used in the US for the primary treatment of uterine fibroids. Unfortunately, this trial is currently on indefinite hold by the sponsor and we are no longer actively recruiting patients. If you would like additional information regarding the status of this trial or other radiology research programs at CHI Baylor St Luke's please contact one of the radiology research nurses at the numbers below:

  • Debra Dees RN 832-355-7501

  • Melissa Andrews RN 832-355-2797

You may obtain additional information about this MRgFUS trial and other studies being performed using this new technology by going to www.clinicaltrials.gov and searching "focused ultrasound". You can also check back here on our web site from time to time for additional information and updates regarding this technology and the study.