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

NCT02618369 | Completed DMC

• 1 other identifier: 1000040583
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoid Osteoma; Benign Bone Tumor; Pain

Keywords

High Intensity Focused Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction in in pain medication usage (NSAIDS, Opioids).

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

Study Arms (1)

MR-HIFU treatment

OTHER

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

Interventions

MR-Guided High Intensity Focused Ultrasound DEVICE

Target treatment of bone lesion using High Intensity Focused Ultrasound

MR-HIFU treatment

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

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

Osteoma, Osteoid; Pain

Condition Hierarchy (Ancestors)

Osteoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; 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 23, 2015
• First Posted: December 1, 2015
• Study Start: April 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)