Actively Recruiting
Radiofrequency Ablation and Bone Augmentation Plus Radiotherapy versus Radiotherapy Alone for Metastatic Spine Disease
Led by University of Minnesota · Updated on 2025-12-03
36
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment for patients with metastatic disease affecting the spine from T5 to L5. The study compares a combination of radiofrequency ablation and bone augmentation (RFA/BA) plus radiotherapy (RT) against radiotherapy alone. The goal is to assess how these treatments impact skeletal-related events (SREs), which include fractures, nerve compression, pain, instability, or the need for additional interventions. This pilot study is randomized and controlled, with patients assigned in a 2:1 ratio to each treatment group. Participants in one group receive radiofrequency-generated heat to destroy cancer cells followed by a bone-stabilizing agent for reinforcement, together with radiotherapy that targets cancer cells with high-energy radiation to provide pain relief and possibly reduce tumor size. The other group receives only radiotherapy. Treatment is given once, and patients are monitored over multiple time points for up to 24 months. Throughout the study, participants will be followed at 1, 3, 6, 12, and 24 months to check for skeletal-related events through clinical and radiologic assessments. Researchers will evaluate the occurrence of fractures, nerve compression, pain, and treatment needs during these visits. Safety and treatment effects will be monitored, with the total duration of participation lasting two years after treatment.
CONDITIONS
Brief Title
Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic disease of the spine from T5 to L5 involving up to two levels as shown 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 lab tests within 14 days before enrollment, including specific blood counts, liver and kidney function measures
- Willingness to use contraception during and for 6 months after treatment if of childbearing potential
- Postmenopausal status or permanent sterilization if applicable
- Voluntary written consent before any research activities
You will not qualify if you...
- Pregnant or breastfeeding individuals
- Clinical or radiologic evidence of epidural spinal cord compression or radicular pain
- Prior radiation therapy to the target lesion
- Candidates for spine stabilization surgery
- Target lesion unsuitable for radiofrequency ablation and bone augmentation due to unstable fractures, involvement of certain spine elements, spinal canal narrowing, bleeding disorders, infection, or purely blastic tumors
- Target lesion size or location beyond safe treatment by radiofrequency ablation as determined by physician discretion
- Mixed lytic/blastic tumors are allowed but purely blastic tumors are excluded
- Active infection anywhere in the body
- Uncontrolled bleeding diathesis or other conditions increasing treatment risks
- Presence of neurological symptoms related to the lesion
- Lesion characteristics that prevent safe procedure performance by the physician's judgment
- Previous spinal interventions that would interfere with study treatments
- Any other condition that may interfere with safe participation or study assessments as determined by investigators
- Lack of informed consent or inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants receive either radiofrequency ablation and bone augmentation plus radiotherapy or radiotherapy alone for metastatic spine disease.
Visits occur at 1, 3, 6, 12, and 24 months for outcome assessments
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
S
Surgery Clinical Trials Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here