NCT02616016

MRI Guided HIFU for Palliation of Painful Skeletal Metastases in Children

Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases in Children - A Pilot Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Metastases
• Pain

Interventions

Type	Name	Description
DEVICE	MRI Guided High Intensity Focused Ultrasound	Target treatment of bone metastases using High Intensity Focused Ultrasound

Timeline

• Start date: 2014-04-01
• Primary completion: 2024-05-02
• Completion: 2024-05-02
• First posted: 2015-11-26
• Last updated: 2024-05-03

Locations

1 site across 1 country: Canada