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Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

NCT07090122 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-03

No results posted yet for this study

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.

Conditions

  • Spine Metastases
  • Bone Pain

Interventions

PROCEDURE

Radiofrequency ablation and bone augmentation with radiotherapy

employs radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent

PROCEDURE

Radiotherapy alone

High-energy radiation

Sponsors & Collaborators

Principal Investigators

  • Reza Talaie · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-01-13
Completion
2028-06-13

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07090122 on ClinicalTrials.gov