To determine treatment safety and efficacy of MR-HIFU ablation of painful Osteoid Osteoma (OO) in children and young adults.
Who can participate
Age range
0 Years – 30 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 ≤30 years.
* Diagnosis of OO: All patients diagnosed with painful OO based on characteristic clinical history of pain relieved with NSAID medications AND confirmatory imaging findings characteristic of OO on CT and/or MRI scans.
* Location of OO: eligible lesions must be located in a bone with acoustic accessibility and within the normal safety margins of MR-HIFU, as specified in the instructions for use.
* Prior therapy: Patients with prior unsuccessful treatments including CT-RFA and/or surgical resection are eligible for enrollment.
* Patients \< 18 years old must be accompanied by a legal guardian at the time of recruitment.
* Laboratory:
* Complete Blood Count (CBC) values within acceptable range for safe administration of anesthesia. Hemoglobin \> 9 g/dL.
* PT, PTT and INR \< 1.5 x ULN (including patients on prophylactic anticoagulation)
* Basic metabolic panel (BMP) and/or Complete metabolic panel (CMP) values within acceptable range for safe administration of anesthesia.
* Adequate renal function: Age-adjusted normal serum creatinine (see table below) OR a creatinine clearance ≥60 mL/min/1.73 m2 for safe contrast administration
* Adequate pulmonary function: Defined as no dyspnea at rest, and a pulse oximetry \>94% on room air.
Exclusion Criteria:
* Diagnosis of bone lesion other than OO in the judgement of the Principal Investigator.
* Clinically significant unrelated systemic illness, such as serious infections, hepatic, renal…
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
1
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v.5
Timeframe: 12 months
2
Pain relief as assessed by pain medication usage
Timeframe: 12 months
3
Pain relief as assessed using the Visual Analog Scale (VAS)
Timeframe: 12 months
4
Pain relief as assessed by using the PROMIS Pain Interference short form
Timeframe: 12 months
5
Quality of life as assessed by using the Pediatric Quality of Life Inventory (PedsQL) v4.0
Timeframe: 12 months
6
Quality of life as assessed by using the Symptom Distress Scale (SDS)