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MR-Guided High Intensity Focused Ultrasound for Pain Management Of Osteoid Osteoma & Benign Bone Tumors in Children and Adults

Primary Purpose

Osteoid Osteoma, Benign Bone Tumor, Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MR-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 Osteoid Osteoma focused on measuring High Intensity Focused Ultrasound

Eligibility Criteria

5 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 5-40 years.
  • Able to give informed consent and have parent or guardian give informed consent if applicable.
  • Weight <140 kg (requirement to fit safely on top of the HIFU table and inside the MRI).
  • Definitive radiographic & clinical presentation of osteoid osteoma or other benign tumor lesion(avoiding need for biopsy).
  • Pain specifically at the site of interest target lesion.
  • Pain score for target lesion >/= 4 (indicating at least moderate pain) or an age-appropriate pain scale.
  • Target lesion is uncomplicated (i.e. no fracture/spinal cord compression/cauda equina syndrome/soft tissue component).
  • MR-HIFU treatment date >/= 2 weeks from most recent surgical treatment of lesion.

Exclusion Criteria:

  • Unable to characterize pain specifically at the site of interest (target lesion).
  • Pregnant/nursing females.
  • Target lesion is complicated (i.e. presence of one of fracture/spinal cord compression/cauda equina syndrome/soft tissue component).
  • Target lesion < 1cm from neurovascular bundles/bowel/hollow viscera or regions of cartilage/ bone growth).
  • Target lesion located in skull, spine (excluding sacrum, which is allowed) or sternum.
  • Scar along proposed HIFU beam path.
  • Orthopaedic implant along proposed HIFU beam path or at site of target tissue.
  • Serious cardiovascular, neurological, renal or haematological chronic disease.
  • Active infection.
  • Contraindication to general anaesthetic or gadolinium MRI contrast agent.
  • Requirement for general anesthesia for non-HIFU related MRI's.

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MR-HIFU treatment

Arm Description

The interventional radiologist will locate the target lesion 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.

Outcomes

Primary Outcome Measures

Change in pain intensity scores from baseline related to the site treated target lesion.
As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days after treatment.

Secondary Outcome Measures

Reduction in in pain medication usage (NSAIDS, Opioids).
As noted in pain diaries by patient before and day 2, 7. 14, 30 and 90 days after treatment.

Full Information

First Posted
November 23, 2015
Last Updated
November 15, 2019
Sponsor
The Hospital for Sick Children
Collaborators
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02618369
Brief Title
MR-Guided High Intensity Focused Ultrasound for Pain Management Of Osteoid Osteoma & Benign Bone Tumors in Children and Adults
Official Title
Magnetic Resonance-Guided High Intensity Focused Ultrasound for Pain Management of Osteoid Osteoma and Benign Bone Tumors in Children and Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
October 2018 (Actual)

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 HIFU system is expected to be efficacious in reducing pain scores in patients with painful osteoid osteoma and other benign bone tumors, and in reducing their pain medication usage. 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 safe and effective technique for alleviating the pain associated with osteoid osteoma and other benign bone tumors in paediatric patients and adults(up to age 40 yrs). This technique meant to be an alternative to the standard-of-care, radiofrequency and laser-based percutaneous ablation. 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 6 months following treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoid Osteoma, Benign Bone Tumor, Pain
Keywords
High Intensity Focused Ultrasound

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
MR-HIFU treatment
Arm Type
Other
Arm Description
The interventional radiologist will locate the target lesion 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.
Intervention Type
Device
Intervention Name(s)
MR-Guided High Intensity Focused Ultrasound
Intervention Description
Target treatment of bone lesion using High Intensity Focused Ultrasound
Primary Outcome Measure Information:
Title
Change in pain intensity scores from baseline related to the site treated target lesion.
Description
As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days after treatment.
Time Frame
2, 7, 14, 30 and 90 days following treatment.
Secondary Outcome Measure Information:
Title
Reduction in in pain medication usage (NSAIDS, Opioids).
Description
As noted in pain diaries by patient before and day 2, 7. 14, 30 and 90 days after treatment.
Time Frame
2, 7, 14, 30 and 90 days following treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 5-40 years. Able to give informed consent and have parent or guardian give informed consent if applicable. Weight <140 kg (requirement to fit safely on top of the HIFU table and inside the MRI). Definitive radiographic & clinical presentation of osteoid osteoma or other benign tumor lesion(avoiding need for biopsy). Pain specifically at the site of interest target lesion. Pain score for target lesion >/= 4 (indicating at least moderate pain) or an age-appropriate pain scale. Target lesion is uncomplicated (i.e. no fracture/spinal cord compression/cauda equina syndrome/soft tissue component). MR-HIFU treatment date >/= 2 weeks from most recent surgical treatment of lesion. Exclusion Criteria: Unable to characterize pain specifically at the site of interest (target lesion). Pregnant/nursing females. Target lesion is complicated (i.e. presence of one of fracture/spinal cord compression/cauda equina syndrome/soft tissue component). Target lesion < 1cm from neurovascular bundles/bowel/hollow viscera or regions of cartilage/ bone growth). Target lesion located in skull, spine (excluding sacrum, which is allowed) or sternum. Scar along proposed HIFU beam path. Orthopaedic implant along proposed HIFU beam path or at site of target tissue. Serious cardiovascular, neurological, renal or haematological chronic disease. Active infection. Contraindication to general anaesthetic or gadolinium MRI contrast agent. Requirement for general anesthesia for non-HIFU related MRI's.
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MR-Guided High Intensity Focused Ultrasound for Pain Management Of Osteoid Osteoma & Benign Bone Tumors in Children and Adults

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