Clinical trial NCT06859801: A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated with Percutaneous Ablation and Palliative Radiation Therapy
Official title: A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated with Percutaneous Ablation and Palliative Radiation Therapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bone Cancer Metastatic
Lead sponsor: Society of Interventional Oncology
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with previously untreated symptomatic, high-risk skeletal metastases who are scheduled to be treated with percutaneous ablation combined with palliative RT as part of their normal Standard of Care (SOC).

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

Primary outcomes:
measure: Pain Response
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: