Magnetic Resonance Imaging–guided Volumetric Ablation of Symptomatic Leiomyomata: Correlation of Imaging with Histology Aradhana M. Venkatesan, MD, Ari Partanen, MSc, Tajana Klepac Pulanic, MD, Matthew R. Dreher, PhD, John Fischer, MD, Robert K. Zurawin, MD, Raja Muthupillai, PhD, Sham Sokka, PhD, Heikki J. Nieminen, PhD, Ninet Sinaii, PhD, MPH, Maria Merino, MD, Bradford J. Wood, MD, and Pamela Stratton, MD Radiology and Imaging Sciences (A.M.V., M.R.D., B.J.W.), NIH Center for Interventional Oncology, 10 Center Drive, Bldg 10, Rm 1C369, MSC 1182, Bethesda, MD 20892; Philips Medical Systems (A.P.), Cleveland, Ohio; Department of Physics (A.P.), University of Helsinki, Helsinki, Finland; Program in Reproductive and Adult Endocrinology Branch (T.K.P., P.S.), Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland; Department of Radiology (J.F., R.K.Z., R.M.), St. Luke’s Episcopal Hospital, Houston, Texas; Department of Obstetrics and Gynecology (R.K.Z.), Baylor College of Medicine, Houston, Texas; Philips Medical Systems (S.S., H.J.N.), Vantaa, Finland; Biostatistics and Clinical Epidemiology Service (N.S.), NIH Clinical Center, Bethesda, Maryland; and Translational Surgical Pathology (M.M.), Surgical Pathology Branch, National Cancer Institute, NIH, Bethesda, Maryland Abstract Purpose—To describe the preliminary safety and accuracy of a magnetic resonance (MR) imaging– guided high-intensity–focused ultrasound (HIFU) system employing new technical developments, including ablation control via volumetric thermal feedback, for the treatment of uterine leiomyomata with histopathologic correlation. Materials and Methods—In this phase I clinical trial, 11 women underwent MR-guided HIFU ablation (Sonalleve 1.5T; Philips Medical Systems, Vantaa, Finland), followed by hysterectomy within 30 days. Adverse events, imaging findings, and pathologic confirmation of ablation were assessed. The relationship between MR imaging findings, thermal dose estimates, and pathology and HIFU spatial accuracy were assessed using Bland-Altman analyses and intraclass correlations. Results—There were 12 leiomyomata treated. No serious adverse events were observed. Two subjects decided against having hysterectomy and withdrew from the study before surgery. Of 11 women, 9 underwent hysterectomy; all leiomyomata demonstrated treatment in the expected location. A mean ablation volume of 6.92 cm 3 ± 10.7 was observed at histopathologic examination. No significant differences between MR imaging nonperfused volumes, thermal dose estimates, and histopathology ablation volumes were observed (P > .05). Mean misregistration values perpendicular to the ultrasound beam axis were 0.8 mm ± 1.2 in feet-head direction and 0.1 mm ± 1.0 in and left-right direction and -0.7 mm ± 3.1 along the axis. © SIR, 2012 Address correspondence to A.M.V.; VenkatesanA@cc.nih.gov. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government. None of the other authors have identified a conflict of interest. NIH Public Access Author Manuscript J Vasc Interv Radiol. Author manuscript; available in PMC 2012 October 02. Published in final edited form as: J Vasc Interv Radiol. 2012 June ; 23(6): 786–794.e4. doi:10.1016/j.jvir.2012.02.015. NIH-PA Author Manuscript NIH-PA Author Manuscript NIH-PA Author Manuscript