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Uterine Leiomyomas: MR Imaging–guided Focused Ultrasound Surgery—Results of Different Treatment Protocols¹

¹ From the Departments of Radiology (F.M.F., C.M.T., N.J.M., M.J.S., K.H., F.A.J.) and Obstetrics and Gynecology (E.A.S.), Harvard Medical School/Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115; Departments of Radiology (G.H.) and Obstetrics and Gynecology (B.G.), Mayo Clinic, Rochester, Minn; Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, Md (H.S.K.); Department of Radiology, Lahey Clinic, Burlington, Mass (G.A.H.); and Radnet Management, Los Angeles, Calif (D.A.S.). From the 2005 RSNA Annual Meeting. Received February 10, 2006; revision requested April 12; revision received July 17; accepted August 23; final version accepted October 4. Supported by InSightec, Haifa, Israel. Supported by National Institutes of Health grants 5R25CA089017-05 (F.A.J., M.J.S.), 5P01CA067165-08 (F.A.J.), and 1U41RR019703-01A2 (F.A.J.). F.M.F. supported by GE AUR Radiology Research Academic Fellowship. Address correspondence to F.M.F. (e-mail: ffennessy{at}partners.org).

Purpose: To prospectively assess patient response (after 12 months) to magnetic resonance (MR) imaging–guided focused ultrasound surgery in treatment of uterine leiomyomas by using two treatment protocols.

Materials and Methods: This prospective clinical trial was approved by institutional review boards and was HIPAA compliant. After giving informed consent, patients with symptomatic leiomyomas were consecutively enrolled and treated at one of five U.S. centers by using an original or a modified protocol. Outcomes were assessed with the symptom severity score (SSS) obtained at baseline and 3, 6, and 12 months after treatment. Adverse events (AEs) were recorded. Statistical analysis included Student t test, Fisher exact test, analysis of covariance, Spearman correlation, and logistic regression.

Results: One hundred sixty patients had a mean SSS of 62.1 ± 16.3 (standard deviation) at baseline, which decreased to 35.5 ± 19.5 at 3 months (P < .001) and to 32.3 ± 19.8 at 6 months (P < .001) and was 32.7 ± 21.0 at 12 months (P < .001). Ninety-six patients (mean age, 46.0 years ± 4.6) were treated with an original protocol, and 64 (mean age, 45.9 years ± 3.9) were treated with a modified protocol. Patients in the modified group had a significantly greater SSS decrease at 3 months (P = .037) than those in the original group, and 73% of those in the original group and 91% of those in the modified group reported a significant decrease in SSS (of 10 points or greater) at 12 months. No serious AEs were recorded. Fewer AEs were reported in the modified group than in the original group (25% vs 13% reporting no event). Of evaluable patients, fewer in the modified group chose alternative treatment (28%) than in the original group (37%).

Conclusion: MR imaging–guided focused ultrasound surgery results in symptomatic improvement, sustained to 12 months after treatment. Treatment with a modified protocol results in greater clinical effectiveness and fewer AEs.

© RSNA, 2007

Clinical trial registration no. IDE G020001-Protocol UF005

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