NCT02923011

Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas

Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Matthew Bucknor · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Accepted

Summary

Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males between ages 10 and 20 years. The goal of the proposed study is based on the premise that MRgFUS is noninferior to CT-guided radiofrequency ablation (CTgRFA), in terms of pain reduction following treatment of osteoid osteomas, and offers possible improvements with regards to 1) post-procedural pain, 2) clinical resource utilization, 3) patient experience, and/or 4) adverse events. The data from the current study would provide clinicians important information in deciding between treatment options for ablation of osteoid osteomas.

Conditions

• Osteoid Osteoma

Interventions

Type	Name	Description
DEVICE	MRgFUS	Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma
DEVICE	CTgRFA	Computed tomography-guided radiofrequency ablation of osteoid osteoma

Timeline

• Start date: 2017-03-28
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2016-10-04
• Last updated: 2025-02-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study