A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutaneous Ablation and Palliative Radiation Therapy
21 Years and older, Male and Female
SIO-2025-01 (primary)
NCI-2025-05519
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
- 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
Treatment Sites in Georgia
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