Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

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.

Study Overview

• Status: Recruiting
• Conditions: Spine Metastases; Bone Pain
• Intervention / Treatment: Procedure: Radiofrequency ablation and bone augmentation with radiotherapy; Procedure: Radiotherapy alone

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Surgery Clinical Trials Office; Phone Number: 612-624-7463; Email: surgCTO@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Deb Mailand; Phone Number: 612-626-2498; Email: mailand@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
  5. total bilirubin ≤ 1.5 × ULN; < 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
  6. serum albumin ≥ 30 g/L (3.0 g/dL)
  7. serum creatinine ≤ 1.5 x ULN; OR estimated glomerular filtration rate (GFR) ≥ 45 mL/min using the Cockcroft Gault formula
• Persons of childbearing potential (POCB) or with partners of childbearing potential must be willing to use contraception during study treatment and 6 months after study treatment.

• Persons are considered to be of childbearing potential unless one or the following applies:

  1. Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause
  2. Considered permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy
• Voluntary written consent prior to the performance of any research related activity

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
Placebo Comparator: Radiotherapy alone; ONLY uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size	Procedure: Radiotherapy alone; High-energy radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal-related event (SREs) outcomes at 1 month	Skeletal-related events 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.	Month 1
Skeletal-related event (SREs) outcomes at 3 months	Skeletal-related events 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.	Month 3
Skeletal-related event (SREs) outcomes at 6 months	Skeletal-related events 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.	Month 6
Skeletal-related event (SREs) outcomes at 12 months	Skeletal-related events 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.	Month 12
Skeletal-related event (SREs) outcomes at 24 months	Skeletal-related events 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.	Month 24

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Reza Talaie, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): January 13, 2028
• Study Completion (Estimated): June 13, 2028

Study Registration Dates

• First Submitted: July 22, 2025
• First Submitted That Met QC Criteria: July 22, 2025
• First Posted (Actual): July 29, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Radiofrequency ablation (RFA); Radiotherapy (RT); Bone augmentation (BA); Metastatic disease of the spine
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Therapy; Radiotherapy; Radiofrequency Ablation
• Other Study ID Numbers: RAD-2023-32509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No