Clinical Trial: MR-Guided High Intensity Focused Ultrasound for Pain Management Of Osteoid Osteoma & Benign Bone Tumors in Children and Adults

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Magnetic Resonance-Guided High Intensity Focused Ultrasound for Pain Management of Osteoid Osteoma and Benign Bone Tumors in Children and Young Adults

Brief Summary: The Philips Sonalleve HIFU system is expected to be efficacious in reducing pain scores in patients with painful osteoid osteoma and other benign bone tumors, and in reducing their pain medication usage. No serious adverse effects are expected to result from this treatment.

Detailed Summary: The objective of this study is to determine if MR-guided high-intensity focused ultrasound (MR-HIFU) is safe and effective technique for alleviating the pain associated with osteoid osteoma and other benign bone tumors in paediatric patients and adults(up to age 40 yrs). This technique meant to be an alternative to the standard-of-care, radiofrequency and laser-based percutaneous ablation. Safety of the technique will be assessed through evaluating non-targeted heating using MRI based temperature mapping. and inspecting patients post treatment for skin burns or other signs of serious adverse events. Efficacy of the technique will be assessed by evaluating/recording patients observed pain, quality of life, and pain medication usage both before and up to 6 months following treatment.
Sponsor: The Hospital for Sick Children

Current Primary Outcome: Change in pain intensity scores from baseline related to the site treated target lesion. [ Time Frame: 2, 7, 14, 30 and 90 days following treatment. ]

As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days after treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome: Reduction in in pain medication usage (NSAIDS, Opioids). [ Time Frame: 2, 7, 14, 30 and 90 days following treatment. ]

As noted in pain diaries by patient before and day 2, 7. 14, 30 and 90 days after treatment.


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: November 23, 2015
Date Started: April 2014
Date Completion: October 2018
Last Updated: October 13, 2016
Last Verified: October 2016