MRI Guided HIFU for Palliation of Painful Skeletal Metastases in Children

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02616016
• Other study ID #: 1000040604
• Status: Withdrawn
• Phase: N/A
• Start date: April 2014
• Est. completion date: May 2, 2024

Study information

• Verified date: May 2024
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2, 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Metastases
• Neoplasm Metastasis
• Pain

Intervention

Device:
• MRI Guided High Intensity Focused Ultrasound
Target treatment of bone metastases using High Intensity Focused Ultrasound

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improved patient quality of life after MR-HIFU using a quality of life questionnaire.	Using age appropriate quality of life questionnaire that involves interviewing patient and/or parent/guardian before and 2, 7, 14, 30 and 90 days post treatment.	2, 7, 14, 30 and 90 days post treatment