MR-HIFU for Osteoma
What You Need to Know Before You Apply
What is the purpose of this trial?
To determine treatment safety and efficacy of MR-HIFU ablation of painful Osteoid Osteoma (OO) in children and young adults.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients on prophylactic anticoagulation (blood thinners) are included, so it might be possible to continue some medications. It's best to discuss your specific medications with the trial team.
Is MR-HIFU treatment generally safe for humans?
How does MR-HIFU treatment for osteoma differ from other treatments?
MR-HIFU (magnetic resonance-guided high-intensity focused ultrasound) is unique because it is a non-invasive treatment that uses focused ultrasound waves to target and destroy the tumor without the need for surgery or exposure to radiation, unlike traditional treatments like radiofrequency ablation.15678
What data supports the effectiveness of the MR-HIFU treatment for osteoma?
Research shows that MR-HIFU (magnetic resonance-guided high-intensity focused ultrasound) is effective in treating osteoid osteoma, a type of benign bone tumor. In a study, 87% of patients experienced complete pain relief, and their quality of life improved significantly, with no major complications reported.146910
Who Is on the Research Team?
Karun Sharma, MD, PhD
Principal Investigator
Children's National Research Institute
Are You a Good Fit for This Trial?
This trial is for children and young adults up to 30 years old with painful Osteoid Osteoma, a type of bone tumor. Participants must have pain relieved by NSAIDs and specific imaging findings. They should be healthy enough for anesthesia, not have significant unrelated illnesses or implants that could interfere with treatment, and the tumor shouldn't be too close to sensitive areas like major nerves or organs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo MR-HIFU ablation procedure of osteoid osteoma under general anesthesia
Follow-up
Participants are monitored for disease status and adverse events following the procedure
Second Treatment (if needed)
Participants with incomplete or partial response at 28 days after MR-HIFU will be permitted a second MR-HIFU procedure
Standard of Care Treatment (if needed)
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
What Are the Treatments Tested in This Trial?
Interventions
- MR-HIFU treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's National Research Institute
Lead Sponsor