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

Last updated: February 17, 2026
Sponsor: Society of Interventional Oncology
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Radiation Therapy

Percutaneous Ablation

Clinical Study ID

NCT06859801
SIO-2025-01
  • Ages > 21
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

    1. Skeletal metastasis with localized pain not controlled medically [recall withinlast 24 hours of worst pain ≥ 5 using the BPI]
    1. Pain must be from one painful metastatic lesion involving the bone (additionalless painful metastatic sites may be present). Extra-osseous extension of disease isallowed (must have some contact with the bone and be causing bone/tumor interfacepain)
    1. Lesions that are at high-risk of skeletal related events defined as follows:
  • a. Minimum Spinal Instability Neoplastic Score (SINS) score ≥ 7 for lesionsinvolving the spine

  • b. Pelvic and appendicular lytic lesions with or without cortical breakthroughcausing functional/mechanical pain

    1. Target lesion amenable to percutaneous ablation with image guidance AND RT byspecialists' review
    1. No prior targeted radiation therapy or ablation to the index lesion
    1. ECOG performance status 0-2
    1. Age ≥ 21 years
    1. Have signed the current approved informed consent form
    1. 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
    1. Life expectancy > 3 months

Exclusion

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 precludethe patient's successful completion of the clinical trial.
    1. Target tumor involves a weight-bearing long bone of the lower extremity with thetumor causing > 50% loss of cortical bone [MIREL Score ≥ 7]
    1. Skeletal lesions with unstable pathologic fractures requiring immediate surgicalstabilization
    1. Concurrent participation in other studies that could affect the primary endpoint
    1. Target tumor causing clinical or imaging evidence of spinal cord compression

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Radiation Therapy
Phase:
Study Start date:
October 23, 2025
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • University of California San Diego Moores Cancer Center

    San Diego 5391811, California 5332921 92093
    United States

    Active - Recruiting

  • Emory University Hospital

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Northside Hospital

    Atlanta 4180439, Georgia 4197000 30342
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • Washington University

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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