Actively Recruiting
A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutaneous Ablation and Palliative Radiation Therapy
Led by Society of Interventional Oncology · Updated on 2026-06-05
120
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating real-world outcomes for patients with symptomatic, high-risk bone metastases who receive both percutaneous ablation and palliative radiation therapy. The study aims to understand effects on pain, patient-reported outcomes, skeletal events, and healthcare use in this population. This observational trial is sponsored by the Society of Interventional Oncology and focuses on adults aged 21 and older with bone metastatic cancer. The study observes patients treated with percutaneous ablation, a minimally invasive method targeting pain-causing nerves and tumor tissues, alongside radiation therapy, which is commonly used to relieve pain from bone metastases. Treatments are given under specialists' review, ensuring lesions are suitable for both procedures. No prior targeted radiation or ablation should have been performed on the lesion to be studied. Participants will be monitored over time through patient-reported outcome surveys like PROMIS®, BPI, COST-FACIT, and OMED for up to 12 months. The primary measure is pain response assessed at three months following treatment. The study also tracks safety, skeletal related events, and healthcare usage, with follow-up focused on those with a life expectancy greater than three months and an ECOG performance status of 0-2.
CONDITIONS
Brief Title
A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutaneous Ablation and Palliative Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Skeletal metastasis with localized pain not controlled by medication, with worst pain of 5 or higher using the Brief Pain Inventory within the last 24 hours
- Pain must come from one painful metastatic bone lesion; extra bone extension causing pain is allowed
- Lesions must be high-risk for skeletal events: spinal lesions with SINS score 7 or higher, or pelvic/appendicular lytic lesions causing functional or mechanical pain
- Target lesion must be suitable for percutaneous ablation and radiation therapy as confirmed by specialists
- No prior targeted radiation therapy or ablation to the lesion
- ECOG performance status between 0 and 2
- Age 21 years or older
- Signed informed consent form
- Willing and able to complete follow-up patient-reported outcome surveys for up to 12 months
- Life expectancy greater than 3 months
You will not qualify if you...
- Any medical or personal condition that may affect safety, compliance, or successful study completion as judged by the investigator
- Tumor involves a weight-bearing long bone of the lower extremity with more than 50% cortical bone loss (MIREL score 7 or higher)
- Skeletal lesions with unstable pathological fractures needing immediate surgical stabilization
- Participation in other studies that may affect the primary outcome
- Tumor causing clinical or imaging evidence of spinal cord compression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo percutaneous ablation as a minimally invasive procedure to treat symptomatic, high-risk bone metastases.
1 visit (in-person)
Duration - Typically 1 to 2 weeks
Participants receive palliative radiation therapy to alleviate pain from bone metastases.
Daily visits during radiation therapy
Duration - Up to 12 months
Participants are followed for pain response and other outcomes for up to 12 months after treatment.
Periodic follow-up visits and patient-reported outcome surveys
Trial Site Locations
Total: 7 locations
1
University of California San Diego Moores Cancer Center
San Diego, California, United States, 92093
Actively Recruiting
2
Baptist Health Medical Group
Miami, Florida, United States, 33176
Actively Recruiting
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
5
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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