Clinical trial · Interventional
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
NCT02618369CI-TRIAL-00076715completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Bone Tumor | Benign Bone Neoplasm | ALIAS | 0.90 |
| Osteoid Osteoma | Osteoid Osteoma | ONTOLOGY_EXACT | 0.98 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-Guided High Intensity Focused Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MR-HIFU treatment
- description
- 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.
- interventionNames
- Device: MR-Guided High Intensity Focused Ultrasound
Primary outcomes (1)
- measure
- Change in pain intensity scores from baseline related to the site treated target lesion.
- timeFrame
- 2, 7, 14, 30 and 90 days following treatment.
- description
- As measured on the pain diaries before and at day 2, 7, 14, 30 and 90 days after treatment.
Secondary outcomes (1)
- measure
- Reduction in in pain medication usage (NSAIDS, Opioids).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.