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