NCT04658771Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 11 Jul 2025
Brief summary (registry, in English)
To determine treatment safety and efficacy of MR-HIFU ablation of painful Osteoid Osteoma (OO) in children and young adults.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Nov 2020
- Start date
- 28 Jan 2021
- Primary completion date
- 11 Jun 2024
- Lead sponsor
- Children's National Research Institute
- NCT number
- NCT04658771
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 28 Jan 2021 to the primary completion date, 11 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Implant, prosthesis or scar tissue that would interfere with a safe completion of MR-HIFU. ablation in the judgement of the Principal Investigator.
- Patients currently receiving any investigational agents.
Other illness
- 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.
Other
- Diagnosis of bone lesion other than OO 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.
Who the study is looking for
- 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.
Age in the registry: 0 years to 30 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's National Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.