PMID- 26413538
OWN - NLM
STAT- MEDLINE
DCOM- 20160714
LR  - 20181113
IS  - 2314-6141 (Electronic)
IS  - 2314-6133 (Print)
VI  - 2015
DP  - 2015
TI  - Volumetric MR-Guided High-Intensity Focused Ultrasound with Direct Skin Cooling 
      for the Treatment of Symptomatic Uterine Fibroids: Proof-of-Concept Study.
PG  - 684250
LID - 10.1155/2015/684250 [doi]
LID - 684250
AB  - 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  approximately  20  degrees 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.
FAU - Ikink, Marlijne E
AU  - Ikink ME
AD  - Department of Radiology, University Medical Center Utrecht, Heidelberglaan 100, 
      3584 CX Utrecht, The Netherlands.
FAU - van Breugel, Johanna M M
AU  - van Breugel JM
AD  - Department of Radiology, University Medical Center Utrecht, Heidelberglaan 100, 
      3584 CX Utrecht, The Netherlands.
FAU - Schubert, Gerald
AU  - Schubert G
AD  - Philips Healthcare, Philips Medical Systems MR, Ayritie 4, 01511 Vantaa, Finland.
FAU - Nijenhuis, Robbert J
AU  - Nijenhuis RJ
AD  - Department of Radiology, University Medical Center Utrecht, Heidelberglaan 100, 
      3584 CX Utrecht, The Netherlands.
FAU - Bartels, Lambertus W
AU  - Bartels LW
AD  - Department of Radiology and Image Sciences Institute, University Medical Center 
      Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
FAU - Moonen, Chrit T W
AU  - Moonen CT
AD  - Department of Radiology and Image Sciences Institute, University Medical Center 
      Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
FAU - van den Bosch, Maurice A A J
AU  - van den Bosch MA
AD  - Department of Radiology, University Medical Center Utrecht, Heidelberglaan 100, 
      3584 CX Utrecht, The Netherlands.
LA  - eng
SI  - NTR/NTR4189
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150830
PL  - United States
TA  - Biomed Res Int
JT  - BioMed research international
JID - 101600173
SB  - IM
MH  - Adult
MH  - Feasibility Studies
MH  - Female
MH  - High-Intensity Focused Ultrasound Ablation/adverse effects/*methods
MH  - Humans
MH  - Leiomyoma/pathology/*therapy
MH  - Magnetic Resonance Imaging/adverse effects/*methods
MH  - Middle Aged
MH  - Prospective Studies
PMC - PMC4568047
EDAT- 2015/09/29 06:00
MHDA- 2016/07/15 06:00
PMCR- 2015/08/30
CRDT- 2015/09/29 06:00
PHST- 2014/07/11 00:00 [received]
PHST- 2014/08/18 00:00 [accepted]
PHST- 2015/09/29 06:00 [entrez]
PHST- 2015/09/29 06:00 [pubmed]
PHST- 2016/07/15 06:00 [medline]
PHST- 2015/08/30 00:00 [pmc-release]
AID - 10.1155/2015/684250 [doi]
PST - ppublish
SO  - Biomed Res Int. 2015;2015:684250. doi: 10.1155/2015/684250. Epub 2015 Aug 30.