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Observational Study of Percutaneous Ablation and Radiation Therapy for Painful Bone Metastases

This study is looking at how well two treatments, percutaneous ablation (a minimally invasive procedure to destroy nerves or tumor tissue) and palliative radiation therapy (a treatment using radiation to relieve pain), work together for people with painful bone metastases (cancer that has spread to the bones). The study aims to understand real-world results, such as how much pain is reduced, how patients feel, and if they need other medical care. You might be able to join if you are 21 or older, have localized bone pain from cancer that isn't controlled by medicine, and your worst pain in the last 24 hours was 5 or higher on a pain scale. The main goal is to see how much your pain improves after 3 months. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information from about 120 participants who receive these treatments as part of their regular care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for pain response is measured at 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06859801

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

Recruiting
Not specifiedAges 21+Observational
Society of Interventional Oncology
~120 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Percutaneous AblationRadiation Therapy

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain Response
Measured over 3 Months

Conditions

Bone Cancer Metastatic

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NCT06859801

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baptist Health Medical Group

    Miami, Floridastudy coordinator listed

    Recruiting

  • Emory University Hospital

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Johns Hopkins Hospital

    Baltimore, Marylandstudy coordinator listed

    Recruiting

  • Mayo Clinic

    Rochester, Minnesotastudy coordinator listed

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

  • Northside Hospital

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • University of California San Diego Moores Cancer Center

    San Diego, Californiastudy coordinator listed

    Recruiting

  • Washington University

    St Louis, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Kathy Velasco
[email protected]
858-822-5677
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Pain Response3 Months

    Combined partial and complete pain response rate using the Brief Pain Inventory (BPI), worst pain 24-hour recall, at 3 months following percutaneous ablation and palliative RT as defined by International Consensus on Palliative Radiotherapy Endpoints in clinical trials (ICPRE). • Partial response is defined as pain reduction of 2 or more at the treated site on a scale of 0 to 10 scale without analgesic increase, or analgesic reduction of 25% or more from Baseline without an increase in pain. • Complete response is defined as a pain score of 0 at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily OMED).