MRI Guided HIFU for Palliation of Painful Skeletal Metastases in Children

NCT02616016 | Withdrawn DMC

• 1 other identifier: 1000040604
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastases; Pain

Outcome Measures

Primary Outcomes (1)

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

  As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days following treatment.

  2, 7, 14, 30 and 90 days following treatment

Secondary Outcomes (1)

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

  2, 7, 14, 30 and 90 days post treatment

Study Arms (1)

MRI guided High Intensity Focused Ultrasound Treatment

OTHER

Intervention Group The interventional radiologist will locate the target tissue and mark the volume to be treated using MRI images. The operator starts the treatment and monitors the progress of the treatment with MR thermal and dose maps to ensure adherence to treatment plan. An individual treatment sonication will last approximately 30 seconds.

Device: MRI Guided High Intensity Focused Ultrasound

Interventions

MRI Guided High Intensity Focused Ultrasound DEVICE

Target treatment of bone metastases using High Intensity Focused Ultrasound

MRI guided High Intensity Focused Ultrasound Treatment

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James M Drake, FRCSC,FACS

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 26, 2015
• Study Start: April 1, 2014
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

CA (1)