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Brief Title: MRI Guided HIFU for Palliation of Painful Skeletal Metastases in Children
Official Title: Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases in Children - A Pilot Study
Study ID: NCT02616016
Brief Summary: The Philips Sonalleve MR-HIFU system is expected to be effective in reducing pain intensity and/or reducing analgesic use in patients with painful uncomplicated bone metastases. No serious adverse effects are expected to result from this treatment.
Detailed Description: The objective of this study is to determine if MR-guided high intensity focused ultrasound (MR-HIFU) is an effective technique for alleviating the pain associated with bone metastases in paediatric cancer patients. This technique meant to be an adjunct therapy to the standard-of-care, which includes radiation therapy and chemotherapy. 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 3 months following treatment.
Minimum Age: 5 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
The Hospital for Sick Children, Toronto, Ontario, Canada
Name: James M Drake, FRCSC,FACS
Affiliation: The Hospital for Sick Children
Role: PRINCIPAL_INVESTIGATOR