Combining percutaneous ablation and palliative radiation for painful, high-risk bone metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational project will collect real-world outcomes in adults with symptomatic, high-risk bone metastases who receive both percutaneous ablation and palliative radiation as part of routine care. Sites will record pain scores, patient-reported outcomes, skeletal-related events, and healthcare utilization before and after treatment. Eligible patients have a single painful bone lesion amenable to image-guided ablation and radiation, are age ≥21, and have ECOG 0–2 with no prior local therapy to the index lesion. Treatments are delivered per treating specialists without randomization, and outcomes are analyzed to describe effectiveness and safety in real practice.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California San Diego Moores Cancer Center
  San Diego, California, United States Recruiting
• Baptist Health Medical Group
  Miami, Florida, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Northside Hospital
  Atlanta, Georgia, United States Recruiting
• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.