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RECRUITING
NCT07090122
NA

Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

Sponsor: University of Minnesota

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-12-01

Completion Date

2028-06-13

Last Updated

2025-12-03

Healthy Volunteers

No

Interventions

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States