Clinical trial · Interventional
MR-HIFU Treatment of Painful Osteoid Osteoma
Pivotal / Phase II Clinical Trial of Magnetic Resonance-Guided Focused Ultrasound (MR-HIFU) Treatment of Painful Osteoid Osteoma in Children and Young Adults
NCT04658771CI-TRIAL-00092035active not recruitingPhase 2ClinicalTrials.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)
To determine treatment safety and efficacy of MR-HIFU ablation of painful Osteoid Osteoma (OO) in children and young adults.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteoid Osteoma | Osteoid Osteoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-HIFU treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients
- description
- Patients will undergo MR-HIFU ablation procedure of OO under general anesthesia. Patients will be monitored for disease status and adverse events for 12 months following procedure. Patients with incomplete or partial response at 28 days after MR-HIFU will be permitted a second MR-HIFU procedure. If there is still incomplete pain relief without medication use by 28 days following the second MR-HIFU treatment, patients will be offered standard of care treatment with RFA and followed for one year.
- interventionNames
- Device: MR-HIFU treatment
Primary outcomes (6)
- measure
- Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v.5
- timeFrame
- 12 months
- description
- CTCAE v.5 will be used
- measure
- Pain relief as assessed by pain medication usage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 30 Years
Show eligibility criteria text
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 or other organ dysfunction, which would compromise the patient's ability to tolerate the general anesthetic required for the procedure in the judgment of the Principal Investigator. * Implant, prosthesis or scar tissue that would interfere with a safe completion of MR-HIFU. ablation in the judgement of the Principal Investigator. * Treatment area nidus \<1 cm from a major nerve, spinal canal, bladder, or bowel. * Target \<1 cm of growth plate (physis). * Lesion in the skull. * Lesion in the vertebral body. * Inability to undergo MRI and/or contraindication for MRI. * Inability to tolerate stationary position during MR-HIFU. * Patients currently receiving any investigational agents.
References
Publications (0)
Data not yet available
No reference posted for this study.