Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

NCT07090122 | Recruiting

• 1 other identifier: RAD-2023-32509
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Radiofrequency ablation (RFA); Bone augmentation (BA); Radiotherapy (RT); Metastatic disease of the spine

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Radiofrequency ablation and bone augmentation with radiotherapy

ACTIVE COMPARATOR

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

Radiotherapy alone

PLACEBO COMPARATOR

ONLY uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size

Procedure: Radiotherapy alone

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

Radiofrequency ablation and bone augmentation with radiotherapy

Radiotherapy alone PROCEDURE

High-energy radiation

Radiotherapy alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• absolute neutrophil count (ANC) ≥ 1.5 × 109/L
• platelets ≥ 50 × 109/L
• hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening
• aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
• total bilirubin ≤ 1.5 × ULN; \< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
• serum albumin ≥ 30 g/L (3.0 g/dL)
• 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:
• Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause
• Considered permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Interventions

Radiofrequency Ablation; Radiotherapy

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Reza Talaie

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Surgery Clinical Trials Office

CONTACT

612-624-7463; surgCTO@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-center, randomized 2 arm controlled pilot study

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 29, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 13, 2028
• Study Completion (Estimated): June 13, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)