Actively Recruiting
Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
Led by University of Minnesota · Updated on 2025-12-03
36
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic disease in the T5-L5 spine region (up to two levels) detected by imaging
- Presence of bone pain or imaging signs predicting skeletal-related events
- Age 18 years or older at consent
- Adequate organ function based on recent laboratory tests including neutrophil count, platelets, hemoglobin, liver enzymes, bilirubin, albumin, and kidney function
- Willingness to use contraception during treatment and for 6 months after if of childbearing potential or with partner of childbearing potential
- Postmenopausal status or permanent sterilization if applicable
- Voluntary written informed consent prior to any study procedures
You will not qualify if you...
- Pregnant or breastfeeding
- Clinical or imaging evidence of epidural spinal cord compression or radicular pain
- Previous radiation therapy to the target spinal lesion
- Candidates for spine stabilization surgery
- Target lesions ineligible for radiofrequency ablation/bone augmentation due to unstable fractures, involvement of posterior spinal elements, retropulsion, spinal canal or neuroforaminal narrowing, bleeding disorders, active infections, or purely blastic tumors
- Lesion size or location unsuitable for safe radiofrequency ablation as determined by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
S
Surgery Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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