MR-HIFU for Osteoma

Overseen by Karun Sharma, MD, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Children's National Research Institute

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

Karun Sharma, MD, PhD

Principal Investigator

Children's National Research Institute

Eligibility Criteria

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

I am 30 years old or younger.

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

I don't have trouble breathing at rest and my oxygen level is above 94%.

Exclusion Criteria

I have a lesion in my spine.

My condition involves the area near the growth plate of a bone.

Inability to undergo MRI and/or contraindication for MRI

Treatment Details

Interventions

• MR-HIFU treatment (Procedure)

Trial Overview The trial is testing MR-HIFU (Magnetic Resonance-guided High-Intensity Focused Ultrasound) ablation as a safe and effective way to treat painful Osteoid Osteoma in patients who may or may not have had unsuccessful prior treatments such as CT-RFA (Computed Tomography-guided Radiofrequency Ablation) or surgery.

Participant Groups

Group I: All patients Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Michelle Riley-Brown

Children's National Research Institute

Chief Executive Officer since 2023

MHA from Washington University School of Medicine in St. Louis, Bachelor's degree from Tulane University

Catherine Bollard

Children's National Research Institute

Chief Medical Officer

MBChB, MD