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Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
Sponsor: University of Minnesota
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
Conditions
Interventions
Radiofrequency ablation and bone augmentation with radiotherapy
employs radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent
Radiotherapy alone
High-energy radiation
Locations (1)
University of Minnesota
Minneapolis, Minnesota, United States