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

Magnetic Resonance-Guided High Intensity Focused Ultrasound for Pain Management of Osteoid Osteoma and Benign Bone Tumors in Children and Young Adults

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.

Study Overview

• Status: Completed
• Conditions: Pain; Osteoid Osteoma; Benign Bone Tumor
• Intervention / Treatment: Device: MR-Guided High Intensity Focused Ultrasound

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital For Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: MR-HIFU treatment; 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.	Device: MR-Guided High Intensity Focused Ultrasound; Target treatment of bone lesion using High Intensity Focused Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2, 7, 14, 30 and 90 days following treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2, 7, 14, 30 and 90 days following treatment.

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: James M Drake, FRCSC, FACS, The Hospital For Sick Children

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (ESTIMATE): December 1, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: High Intensity Focused Ultrasound
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Bone Neoplasms; Osteoma; Osteoma, Osteoid
• Other Study ID Numbers: 1000040583

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO