NCT06859801 A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutaneous Ablation and Palliative Radiation Therapy
| NCT ID | NCT06859801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Society of Interventional Oncology |
| Condition | Bone Cancer Metastatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-10-23 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Frequently Asked Questions
Who can join the NCT06859801 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Bone Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06859801 currently recruiting?
Yes, NCT06859801 is actively recruiting participants. Visit ClinicalTrials.gov or contact Society of Interventional Oncology to inquire about joining.
Where is the NCT06859801 trial being conducted?
This trial is being conducted at San Diego, United States, Miami, United States, Atlanta, United States, Atlanta, United States and 4 additional locations.
Who is sponsoring the NCT06859801 clinical trial?
NCT06859801 is sponsored by Society of Interventional Oncology. The trial plans to enroll 120 participants.
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