Back to Trials
NCT06859801Recruiting

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

Society of Interventional Oncology

Start Date

10/23/2025

Completion Date

7/31/2027

Summary

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).

Eligibility Criteria

Age Range: 21 years to No maximum

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

Interventions

DEVICE

Percutaneous Ablation

RADIATION

Radiation Therapy

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Bone Cancer Metastatic

Locations

University of California San Diego Moores Cancer Center

San Diego, California 92093

United States

Baptist Health Medical Group

Miami, Florida 33176

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Northside Hospital

Atlanta, Georgia 30342

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Washington University

St Louis, Missouri 63110

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States