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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Target treatment of bone lesion using High Intensity Focused Ultrasound
The Hospital for Sick Children
Toronto, Ontario, Canada
Change in pain intensity scores from baseline related to the site treated target lesion.
As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days after treatment.
Time frame: 2, 7, 14, 30 and 90 days following treatment.
Reduction in in pain medication usage (NSAIDS, Opioids).
As noted in pain diaries by patient before and day 2, 7. 14, 30 and 90 days after treatment.
Time frame: 2, 7, 14, 30 and 90 days following treatment.
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