title: Volumetric MR-Guided High-Intensity Focused Ultrasound with Direct Skin Cooling for the Treatment of Symptomatic Uterine Fibroids: Proof-of-Concept Study.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
authors.forename: Marlijne E
authors.initials: ME
authors.lastname: Ikink
authors.affiliation: Department of Radiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
authors.forename: Johanna M M
authors.initials: JM
authors.lastname: van Breugel
authors.affiliation: Philips Healthcare, Philips Medical Systems MR, Äyritie 4, 01511 Vantaa, Finland.
authors.forename: Gerald
authors.initials: G
authors.lastname: Schubert
authors.affiliation: Department of Radiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
authors.forename: Robbert J
authors.initials: RJ
authors.lastname: Nijenhuis
authors.affiliation: Department of Radiology and Image Sciences Institute, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
authors.forename: Lambertus W
authors.initials: LW
authors.lastname: Bartels
authors.affiliation: Department of Radiology and Image Sciences Institute, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
authors.forename: Chrit T W
authors.initials: CT
authors.lastname: Moonen
authors.affiliation: Department of Radiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
authors.forename: Maurice A A J
authors.initials: MA
authors.lastname: van den Bosch
mesh_terms: D000328:Adult; D005240:Feasibility Studies; D005260:Female; D057086:High-Intensity Focused Ultrasound Ablation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007889:Leiomyoma / Q000473:pathology / Q000628:therapy*; D008279:Magnetic Resonance Imaging / Q000009:adverse effects / Q000379:methods*; D008875:Middle Aged; D011446:Prospective Studies