Volumetric MR-Guided High-Intensity Focused Ultrasound with Direct Skin Cooling for the Treatment of Symptomatic Uterine Fibroids: Proof-of-Concept Study

Abstract EN

Objective.

To prospectively assess the safety and technical feasibility of volumetric magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) ablation with direct skin cooling (DISC) during treatment of uterine fibroids.

Methods.

In this proof-of-concept study, eight patients were consecutively selected for clinical MR-HIFU ablation of uterine fibroids with the use of an additional DISC device to maintain a constant temperature (T≈20°C) at the interface between the HIFU table top and the skin.

Technical feasibility was verified by successful completion of MR-HIFU ablation.

Contrast-enhanced T1-weighted MRI was used to measure the treatment effect (nonperfused volume (NPV) ratio).

Safety was evaluated by recording of adverse events (AEs) within 30 days’ follow-up.

Results.

All MR-HIFU treatments were successfully completed in an outpatient setting.

The median NPV ratio was 0.56 (IQR [0.27–0.72]).

Immediately after treatment, two patients experienced coldness related discomfort which resolved at the same day.

No serious (device-related) AEs were reported.

Specifically, no skin burns, cold injuries, or subcutaneous edema were observed.

Conclusion.

This study showed that it is safe and technically feasible to complete a volumetric MR-HIFU ablation with DISC.

This technique may reduce the risk of thermal injury to the abdominal wall during MR-HIFU ablation of uterine fibroids.

This trial is registered with NTR4189.