Document Detail


Magnetic resonance imaging-guided volumetric ablation of symptomatic leiomyomata: correlation of imaging with histology.
MedLine Citation:
PMID:  22626269     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
CONCLUSIONS: Safe, accurate ablation of uterine leiomyomata was achieved with an MR-guided HIFU system with novel treatment monitoring capabilities, including ablation control via volumetric thermal feedback.
Authors:
Aradhana M Venkatesan; Ari Partanen; Tajana Klepac Pulanic; Matthew R Dreher; John Fischer; Robert K Zurawin; Raja Muthupillai; Sham Sokka; Heikki J Nieminen; Ninet Sinaii; Maria Merino; Bradford J Wood; Pamela Stratton
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, N.I.H., Intramural    
Journal Detail:
Title:  Journal of vascular and interventional radiology : JVIR     Volume:  23     ISSN:  1535-7732     ISO Abbreviation:  J Vasc Interv Radiol     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-05-25     Completed Date:  2012-09-24     Revised Date:  2013-06-24    
Medline Journal Info:
Nlm Unique ID:  9203369     Medline TA:  J Vasc Interv Radiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  786-794.e4     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 SIR. Published by Elsevier Inc. All rights reserved.
Affiliation:
Radiology and Imaging Sciences, NIH Center for Interventional Oncology, Bethesda, MD 20892, USA. VenkatesanA@cc.nih.gov
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00837161
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MeSH Terms
Descriptor/Qualifier:
Adult
Female
High-Intensity Focused Ultrasound Ablation* / adverse effects
Humans
Hysterectomy
Leiomyoma / pathology,  surgery*
Magnetic Resonance Imaging, Interventional*
Maryland
Middle Aged
Predictive Value of Tests
Prospective Studies
Texas
Time Factors
Treatment Outcome
Tumor Burden
Uterine Neoplasms / pathology,  surgery*
Grant Support
ID/Acronym/Agency:
Z99 CL999999/CL/CLC NIH HHS; ZIA CL040011-04/CL/CLC NIH HHS; ZIA CL040012-04/CL/CLC NIH HHS; ZIA CL040015-03/CL/CLC NIH HHS; ZIA HD008891-03/HD/NICHD NIH HHS; ZID BC011242-03/BC/NCI NIH HHS
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