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

Sponsor: Society of Interventional Oncology · NCT06859801 on ClinicalTrials.gov ↗

Conditions studied

Bone Cancer Metastatic

What it tests

  • Percutaneous Ablationdevice
  • Radiation Therapyradiation

Where it's running7 sites

  • University of California San Diego Moores Cancer Center

    San Diego, California 92093

    Recruiting now
  • Baptist Health Medical Group

    Miami, Florida 33176

    Recruiting now
  • Emory University Hospital

    Atlanta, Georgia 30322

    Recruiting now
  • Northside Hospital

    Atlanta, Georgia 30342

    Recruiting now
  • Mayo Clinic

    Rochester, Minnesota 55905

    Recruiting now
  • Washington University

    St Louis, Missouri 63110

    Recruiting now
  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226

    Recruiting now
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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

Updated 2026-06-05 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.