Nan Jiang1, Bin Xie, Xin Zhang, Min He, Kequan Li, Jin Bai, Zhibiao Wang, Jia He, Lian Zhang. 1. State Key Laboratory of Ultrasound Engineering in Medicine Co-founded by Chongqing and the Ministry of Science and Technology, Chongqing Key Laboratory of Ultrasound in Medicine and Engineering, College of Biomedical Engineering, Chongqing Medical University, Chongqing, 400016, China, 350590169@qq.com.
Abstract
PURPOSE: To evaluate the role of the ultrasound contrast agent SonoVue in enhancing the ablation effects of ultrasound-guided high-intensity focused ultrasound (HIFU) on uterine fibroids. METHODS:Eighty patients with solitary uterine fibroids at a single center were randomly assigned to a control or SonoVue group. Of these, 40 were treated using HIFU alone; 40 who were pretreated with SonoVue received a bolus before the HIFU procedure. All patients underwent magnetic resonance imaging (MRI) scan before and after HIFU treatment. RESULTS: The post-HIFU MRI showed the nonperfused volume (NPV) in all of the treated uterine fibroids; the mean fractional ablation (NPV ratio) was 90.4 ± 8.3 % (range 66.4-100 %) in the SonoVue group and 82.8 ± 13.3 % (range 53.4-100 %) in the control group. The frequency of massive gray-scale changes that occurred during HIFU was greater in the group that received SonoVue than the group that did not. The average sonication time to reach massive gray-scale changes was significantly shorter in the group receiving SonoVue than the group without SonoVue. The acoustic energy for treating 1 mm(3) of uterine fibroid was less in the SonoVue group than the control group. No any major complication occurred in this study. CONCLUSION: Based on the results of this randomized controlled trial, SonoVue could be safely used to enhance the effects of HIFU treatment for uterine fibroids.
RCT Entities:
PURPOSE: To evaluate the role of the ultrasound contrast agent SonoVue in enhancing the ablation effects of ultrasound-guided high-intensity focused ultrasound (HIFU) on uterine fibroids. METHODS: Eighty patients with solitary uterine fibroids at a single center were randomly assigned to a control or SonoVue group. Of these, 40 were treated using HIFU alone; 40 who were pretreated with SonoVue received a bolus before the HIFU procedure. All patients underwent magnetic resonance imaging (MRI) scan before and after HIFU treatment. RESULTS: The post-HIFU MRI showed the nonperfused volume (NPV) in all of the treated uterine fibroids; the mean fractional ablation (NPV ratio) was 90.4 ± 8.3 % (range 66.4-100 %) in the SonoVue group and 82.8 ± 13.3 % (range 53.4-100 %) in the control group. The frequency of massive gray-scale changes that occurred during HIFU was greater in the group that received SonoVue than the group that did not. The average sonication time to reach massive gray-scale changes was significantly shorter in the group receiving SonoVue than the group without SonoVue. The acoustic energy for treating 1 mm(3) of uterine fibroid was less in the SonoVue group than the control group. No any major complication occurred in this study. CONCLUSION: Based on the results of this randomized controlled trial, SonoVue could be safely used to enhance the effects of HIFU treatment for uterine fibroids.