Combining percutaneous ablation and palliative radiation for painful, high-risk bone metastases
A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutaneous Ablation and Palliative Radiation Therapy
This project tests whether giving percutaneous ablation together with palliative radiation helps reduce pain and other problems in adults with a single symptomatic, high-risk bone metastasis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Society of Interventional Oncology Academic / other |
| Drugs / interventions | radiation |
| Locations | 6 sites (San Diego, California and 5 other locations) |
| Trial ID | NCT06859801 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥21) with one painful, high-risk bone metastasis amenable to image-guided percutaneous ablation and palliative radiation, ECOG 0–2, and no prior targeted therapy to the index lesion.
Not a fit: Patients with multiple uncontrolled painful lesions, poor performance status (ECOG >2), lesions not suitable for percutaneous ablation, or prior radiation/ablation to the target lesion are unlikely to gain benefit from this combined approach.
Why it matters
Potential benefit: If successful, the findings could support wider use of combined ablation and radiation to improve pain control and reduce skeletal complications for patients with high-risk bone metastases.
How similar studies have performed: Small series and retrospective reports have shown that ablation and palliative radiation each reduce pain and some combined-therapy reports suggest added benefit, but prospective multi-center real-world data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Diego, California and 5 other locations
- University of California San Diego Moores Cancer Center — San Diego, California, United States (Recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Not_yet_recruiting)
- Northside Hospital — Atlanta, Georgia, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Washington University — St Louis, Missouri, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.