Researchers are using new generation of MR-guided focused ultrasound equipment to treat patients with uterine fibroids and pain from metastatic bone tumors.
Dedicated in September 2009, the Foundation-sponsored Focused Ultrasound Center of Excellence at the University of Virginia Health System in Charlottesville has taken the first steps in building a robust, multi-disciplinary clinical trial program.
Recently launched, the center’s first clinical trial is a pivotal (Phase 3) study investigating the safety and efficacy of MR-guided focused ultrasound treatment for pain associated with metastatic bone tumors. Typically, pivotal studies support the submission of a premarket approval (PMA) application to the FDA for a new device or a new use of that device. In this case, research is supporting a new use of Insightec’s ExAblate 2000, which received FDA approval for the treatment of uterine fibroids in 2004.
The UVA center will begin two more clinical trials this summer. One will be a feasibility (pilot) study of the safety and initial efficacy of the new ExAblate 2100 Conformal Bone System in treating pain resulting from metastatic bone tumors. UVA will be one of two sites conducting this study, which is expected to enroll a total of 50 patients.
The second study will evaluate the safety of the ExAblate 2100 Uterine Fibroid V2 System in treating symptomatic uterine fibroids.
The studies are being funded by InSightec of Triat Carmel, Israel, manufacturer of ExAblate systems.
Alan Matsumoto,M.D., chair of UVA’s Department of Radiology, will be principal investigator of a clinical trial of a new generation ExAblate system for the treatment of uterine fibroids.
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain in Patients Who are not Candidates for Radiation Therapy (Principal Investigator: Paul Read, M.D., Department of Radiation Oncology)
Link to study information:
A Feasibility Study to Evaluate the Safety and Initial Effectiveness of ExAblate MR-Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System (Principal investigator: Paul Read, M.D., Department of Radiation Oncology)
A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids (Principal investigator: Alan Matsumoto, M.D., Department of Radiology)
Written by Ellen C., McKenna