A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutaneous Ablation and Palliative Radiation Therapy (TRIBUTE)

The objective of this study is to evaluate real-world outcomes (e.g., pain, patient reported outcomes, skeletal related events, healthcare utilization, etc.) in patients treated with both percutaneous ablation and palliative radiation therapy (RT).

Study Overview

• Status: Recruiting
• Conditions: Bone Cancer Metastatic
• Intervention / Treatment: Device: Percutaneous Ablation; Radiation: Radiation Therapy

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • Recruiting
      • University of California San Diego Moores Cancer Center
      • Contact: Kathy Velasco; Phone Number: 858-822-5677; Email: kcvelasco@health.ucsd.edu
      • Principal Investigator: Anthony Tadros, MD
      • Principal Investigator: Kathryn Tringale, MD
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Northside Hospital
      • Contact: Shannon Gleason; Phone Number: 404-303-3355; Email: clinical.trials@northside.com
      • Principal Investigator: Jason Levy, MD
      • Principal Investigator: Mudit Chowdhary, MD
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
      • Emory University Hospital
      • Contact: Maria Rivas; Phone Number: 404-712-7962; Email: mrivas2@emory.edu
      • Principal Investigator: Junjian Huang, MD
      • Principal Investigator: Rohini Bhatia, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Desirae Howe-Clayton; Phone Number: 507-255-0111; Email: howe.desirae@mayo.edu
      • Principal Investigator: Brian Welch, MD
      • Principal Investigator: Sean Park, MD
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University
      • Principal Investigator: Joanna Yang, MD
      • Contact: Addie Lovato; Phone Number: 314-362-4263; Email: lovato@wustl.edu
      • Principal Investigator: Resten Imaoka, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Not yet recruiting
      • Medical College of Wisconsin
      • Contact: Kyersten Hoene; Phone Number: 9209796340; Email: khoene@mcw.edu
      • Principal Investigator: Matthew Scheidt, MD
      • Principal Investigator: Meena Bedi, MD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with previously untreated symptomatic, high-risk skeletal metastases who are scheduled to be treated with percutaneous ablation combined with palliative RT as part of their normal Standard of Care (SOC).

Description

Inclusion Criteria:

• 1. Skeletal metastasis with localized pain not controlled medically [recall within last 24 hours of worst pain ≥ 5 using the BPI]
• 2. Pain must be from one painful metastatic lesion involving the bone (additional less painful metastatic sites may be present). Extra-osseous extension of disease is allowed (must have some contact with the bone and be causing bone/tumor interface pain)
• 3. Lesions that are at high-risk of skeletal related events defined as follows:
• a. Minimum Spinal Instability Neoplastic Score (SINS) score ≥ 7 for lesions involving the spine
• b. Pelvic and appendicular lytic lesions with or without cortical breakthrough causing functional/mechanical pain
• 4. Target lesion amenable to percutaneous ablation with image guidance AND RT by specialists' review
• 5. No prior targeted radiation therapy or ablation to the index lesion
• 6. ECOG performance status 0-2
• 7. Age ≥ 21 years
• 8. Have signed the current approved informed consent form
• 9. Willing and able to answer follow-up Patient Reported Outcomes (PRO) surveys (e.g., PROMIS®, BPI, COST-FACIT, and OMED) for up to 12 months
• 10. Life expectancy > 3 months

Exclusion Criteria:

• 1. Any medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial.
• 2. Target tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone [MIREL Score ≥ 7]
• 3. Skeletal lesions with unstable pathologic fractures requiring immediate surgical stabilization
• 4. Concurrent participation in other studies that could affect the primary endpoint
• 5. Target tumor causing clinical or imaging evidence of spinal cord compression

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Response	Combined partial and complete pain response rate using the Brief Pain Inventory (BPI), worst pain 24-hour recall, at 3 months following percutaneous ablation and palliative RT as defined by International Consensus on Palliative Radiotherapy Endpoints in clinical trials (ICPRE). • Partial response is defined as pain reduction of 2 or more at the treated site on a scale of 0 to 10 scale without analgesic increase, or analgesic reduction of 25% or more from Baseline without an increase in pain. • Complete response is defined as a pain score of 0 at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily OMED).	3 Months

Collaborators and Investigators

• Sponsor: Society of Interventional Oncology

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Bone Neoplasms; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Ablation; Radiofrequency Therapy; Radiotherapy; Catheter Ablation
• Other Study ID Numbers: SIO-2025-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No