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

NCT ID: NCT06859801

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-07-31

Brief 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).

Conditions

Bone Cancer Metastatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Percutaneous Ablation

Percutaneous ablation is a minimally invasive alternative therapy for metastatic bone disease and can be used for destruction of nerves mediating pain signals, tumor destruction, decompression, or inhibition of tumor growth.

Intervention Type: DEVICE

Radiation Therapy

Radiation therapy (RT) is a widely accepted treatment for painful bone metastases and provides palliation of pain for patients.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Society of Interventional Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SIO-2025-01

Identifier Type: -

Identifier Source: org_study_id