Clinical trial NCT02616016: 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bone Metastases
Pain
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
First posted: 2015-11-26
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* able to give informed consent
* weight \<140 kg (requirement to fit safely on top of the HIFU table and inside MRI
* any radiologic evidence of bone metastases from any solid tumor (neuroblastoma, osteosarcoma, soft tissue sarcoma, or any other solid tumor metastases).
* pain specifically at the site of interest (target lesion)
* pain score for target lesion \>/ = 4 (indicating at least moderate pain) on an age-appropriate 0-10 point scale
* Target lesion in uncomplicated (ie no fracture / spinal cord compression /cauda equine syndrome/ soft tissue component)
* Available 3D MRI image of the target lesion (or be able to obtain one in a clinically feasible amount of time as part of the baseline investigational stage.)
* Proposed MR-HIFU treatment date \>/= 2 weeks from most recent treatment of target tumour or systems chemotherapy
* Proposed MR-HIFU treatment date \>/= 1 week after administration of steroids for pain flare

Exclusion Criteria:

* Unable to characterize pain specifically at the site of interest (target lesion).
* Pregnant / nursing females
* Target lesion is complicated (ie pressure of one fracture /spinal cord compression/cauda equine syndrome/soft tissue component)
* Target lesion \< 1cm from nerve bundles/ bladder/bowel
* Target lesion in contact with hollow viscera
* Target lesion located in skull, spine (excluding sacrum which is allowed) or sternum.
* scar along proposed HIFU beam path.
* Orthopaedic implant along proposed HIIFU beam path or at site of target lesion.
* Active infection.
* Contradiction to general anesthesia or or gadolinium MRI contrast agent.
* Requirement for general anaesthesia for non -HIFU related MRI scans.

Primary outcomes:
measure: Change in pain intensity scores from baseline as measured on pain diaries.
timeFrame: 2, 7, 14, 30 and 90 days following treatment
Secondary outcomes:
measure: Improved patient quality of life after MR-HIFU using a quality of life questionnaire.
timeFrame: 2, 7, 14, 30 and 90 days post treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: James M Drake, FRCSC,FACS
role: PRINCIPAL_INVESTIGATOR
References: