CompletedNot Applicable

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

Canada10 participantsStarted 2014-04

Plain-language 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.

Who can participate

Age range

5 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * Requirem…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pain intensity scores from baseline related to the site treated target lesion.

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

Trial details

NCT IDNCT02618369

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04

View on ClinicalTrials.gov More Osteoid Osteoma trials

Who can participate

Age range

5 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.