Condition: Spine Metastases · Bone Pain · Sponsor: University of Minnesota
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.
This description comes directly from the study's public registry record.
Surgery Clinical Trials Office · 612-624-7463 · surgCTO@umn.edu
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| University of Minnesota | Minneapolis, Minnesota, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07090122