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

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.

Trial Description

Primary Outcome:

• Change in pain intensity scores from baseline as measured on pain diaries.

Secondary Outcome:

• Improved patient quality of life after MR-HIFU using a quality of life questionnaire.

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.

View this trial on ClinicalTrials.gov