Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Minnesota
You may qualify if…
- ✓ Histologically confirmed metastatic T5-L5 disease of the spine (with up to two levels) as detected by any imaging study.
- ✓ Have either associated bone pain or cross-sectional imaging characteristics that are predictors of SRE.
- ✓ Age 18 years of age or older at the time of consent.
- ✓ Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to study enrollment defined as:
- ✓ 1. absolute neutrophil count (ANC) ≥ 1.5 × 109/L
- ✓ 2. platelets ≥ 50 × 109/L
- ✓ 3. hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening
- ✓ 4. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
You may not qualify if…
- ✕ Pregnant or breastfeeding.
- ✕ Clinical or radiologic evidence of epidural spinal cord compression or radicular pain.
- ✕ Prior radiation therapy to the target lesion.
- ✕ Candidates for spine stabilization surgery.
- ✕ The target lesion(s) is deemed ineligible for RFA/BA (e.g. unstable existing fractures/impending fractures, involvement of the posterior elements, retropulsion, spinal canal narrowing, neuroforaminal narrowing, uncontrolled bleeding diathesis, active infection anywhere in the body, or purely blastic tumor). Note: Mixed lytic/blastic tumors are eligible.
- ✕ The target lesion(s) size or location is beyond RFAs ability to safely perform, at the physician's discretion
Where it's recruiting
Minneapolis
Source: ClinicalTrials.gov · NCT07090122 · last updated 2025-12-03