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MRI Guided HIFU for Palliation of Painful Skeletal Metastases in Children

Primary Purpose

Bone Metastases, Pain

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MRI Guided High Intensity Focused Ultrasound
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Metastases

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MRI guided High Intensity Focused Ultrasound Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 18, 2015
Last Updated
July 13, 2021
Sponsor
The Hospital for Sick Children
Collaborators
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02616016
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI guided High Intensity Focused Ultrasound Treatment
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MRI Guided High Intensity Focused Ultrasound
Intervention Description
Target treatment of bone metastases using High Intensity Focused Ultrasound
Primary Outcome Measure Information:
Title
Change in pain intensity scores from baseline as measured on pain diaries.
Description
As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days following treatment.
Time Frame
2, 7, 14, 30 and 90 days following treatment
Secondary Outcome Measure Information:
Title
Improved patient quality of life after MR-HIFU using a quality of life questionnaire.
Description
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.
Time Frame
2, 7, 14, 30 and 90 days post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James M Drake, FRCSC,FACS
Phone
416-813-6125
Email
james.drake@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Homa Ashrafpour
Phone
416-813-1500
Ext
328771
Email
homa.ashrafpour@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James M Drake, FRCSC,FACS
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James M Drake, FRCSC,FACS
Phone
416-813-6125
Email
james.drake@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Homa Ashrafpour
Phone
416-813-1500
Ext
328771
Email
homa.ashrafpour@sickkids.ca

12. IPD Sharing Statement

Learn more about this trial

MRI Guided HIFU for Palliation of Painful Skeletal Metastases in Children

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