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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618369
• Other study ID #: 1000040583
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: October 2018

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Bone Tumor
• Bone Neoplasms
• Osteoid Osteoma
• Osteoma, Osteoid
• Pain

Intervention

Device:
• MR-Guided High Intensity Focused Ultrasound
Target treatment of bone lesion 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 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	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.