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

RECRUITING

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

NCT06859801•Society of Interventional Oncology

View on ClinicalTrials.gov

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

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

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

Locations (6)

University of California San Diego Moores Cancer Center

San Diego, California, United States

Emory University Hospital

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

October 23, 2025

Primary Completion Date

July 31, 2027

Completion Date

July 31, 2027

Last Updated

February 19, 2026

Enrollment

120

ESTIMATED participants

Conditions

Bone Cancer Metastatic

Interventions

Percutaneous Ablation

DEVICE

Radiation Therapy

RADIATION