NCT07090122

Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, randomized controlled pilot study of radiofrequency ablation and bone augmentation (RFA/BA) plus radiotherapy (RT) vs. RT alone in patients with metastatic T5-L5 disease of the spine. Patients will be randomized 2:1 to receive either one treatment of RFA/BA plus RT or RT to evaluate the occurrence of skeletal-related events. Skeletal-related events (SREs) are defined as new clinical or radiologic evidence of pathologic fracture, spinal cord or nerve root compression, pain or instability, and/or necessity for additional local intervention (i.e. surgery, repeat RFA/BA or RT) due to persistent or progressive symptoms. Post-treatment follow-up for SREs are assessed at 1, 3, 6, 12, and 24 months.

Conditions

• Spine Metastases
• Bone Pain

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency ablation and bone augmentation with radiotherapy	employs radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent
PROCEDURE	Radiotherapy alone	High-energy radiation

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-01-13
• Completion: 2028-06-13
• First posted: 2025-07-29
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States