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Recruiting NCT06859801

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

— Observational Bone Cancer Metastatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Percutaneous Ablation, Radiation Therapy.
Who it may be relevant to
Registry conditions: Bone Cancer Metastatic. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

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

Primary outcome measures

  • Pain Response [Time frame: 3 Months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 7 centers
  • University of California San Diego Moores Cancer Center — San Diego
  • Baptist Health Medical Group — Miami
  • Emory University Hospital — Atlanta
  • Northside Hospital — Atlanta
  • Mayo Clinic — Rochester
  • Washington University — St Louis
  • Medical College of Wisconsin — Milwaukee

Identifiers

NCT: NCT06859801 · SIO-2025-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗