Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07090122
Status
Recruiting
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Conditions

  • Bone Pain
  • Spine Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiofrequency ablation and bone augmentation with radiotherapy — PROCEDURE
    employs radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent
  • Radiotherapy alone — PROCEDURE
    High-energy radiation

Study Details

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 Dates

Start date
Dec 1, 2025
Status verified
Dec 2025
Primary completion
Jan 13, 2028
Completion
Jun 13, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Radiofrequency ablation and bone augmentation with radiotherapy
    Radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent to offer both tumor control and structural reinforcement. Radiotherapy (RT) uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size
  • Placebo Comparator: Radiotherapy alone
    ONLY uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size

Primary Outcome Measure

Skeletal-related event (SREs) outcomes at 1 month [ Time Frame: Month 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Deb Mailand
[email protected]
612-626-2498

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By research site
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