TY - JOUR
T1 - Magnetic resonance imaging-guided volumetric ablation of symptomatic leiomyomata
T2 - Correlation of imaging with histology
AU - Venkatesan, Aradhana M.
AU - Partanen, Ari
AU - Pulanic, Tajana Klepac
AU - Dreher, Matthew R.
AU - Fischer, John
AU - Zurawin, Robert K.
AU - Muthupillai, Raja
AU - Sokka, Sham
AU - Nieminen, Heikki J.
AU - Sinaii, Ninet
AU - Merino, Maria
AU - Wood, Bradford J.
AU - Stratton, Pamela
N1 - Funding Information:
This work was supported in part by the NIH Center for Interventional Oncology, NIH Intramural Research Training Program, Program in Reproductive and Adult Endocrinology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, by the NIH Clinical Center via a Cooperative Research and Development Agreement (CRADA) between NIH and Philips Healthcare, and by the National Cancer Institute under Contract No. HHSN261200800001E.
PY - 2012/6
Y1 - 2012/6
N2 - 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 cm3 ± 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.
AB - 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 cm3 ± 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.
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U2 - 10.1016/j.jvir.2012.02.015
DO - 10.1016/j.jvir.2012.02.015
M3 - Article
C2 - 22626269
AN - SCOPUS:84861540732
SN - 1051-0443
VL - 23
SP - 786-794.e4
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
IS - 6
ER -