ObjectiveThe purpose of this prospective multicenter study was to assess the safety and technical feasibility of volumetric Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) ablation for treatment of patients with symptomatic uterine fibroids.MethodsThirty-three patients with 36 fibroids were treated with volumetric MR-HIFU ablation. Treatment capability and technical feasibility were assessed by comparison of the Non-Perfused Volumes (NPVs) with MR thermal dose predicted treatment volumes. Safety was determined by evaluation of complications or adverse events and unintended lesions. Secondary endpoints were pain and discomfort scores, recovery time and length of hospital stay.ResultsThe mean NPV calculated as a percentage of the total fibroid volume was 21.7%. Correlation between the predicted treatment volumes and NPVs was found to be very strong, with a correlation coefficient r of 0.87. All patients tolerated the treatment well and were treated on an outpatient basis. No serious adverse events were reported and recovery time to normal activities was 2.3 ± 1.8 days.ConclusionThis prospective multicenter study proved that volumetric MR-HIFU is safe and technically feasible for the treatment of symptomatic uterine fibroids.Key Points• Magnetic-resonance-guided high intensity focused ultrasound allows non-invasive treatment of uterine fibroids.• Volumetric feedback ablation is a novel technology that allows larger treatment volumes• MR-guided ultrasound ablation of uterine fibroids appears safe using volumetric feedback

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• Volumetric MR-guided high-intensity focused ultrasound is a novel ablation technique for leiomyomatosis. • We prospectively evaluated the outcome of volumetric MR-HIFU ablation for symptomatic fibroids. • This study showed that volumetric MR-HIFU results in an effective treatment. • A randomised controlled trial would set this technique in an appropriate context.

Sonication accuracy of volumetric MR imaging-guided high-intensity focused ultrasound ablation of uterine fibroids appears clinically acceptable and may be further improved by feedback control to produce more consistent ablation zones.