NCT06716294

Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By Positron Emission Computed Tomography (PET-CT) Confirmation

Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET-CT Confirmation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 16 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This pilot study will try to demonstrate metabolic changes in spine lesions treated by Augmentation and Ablation, according to existing standards of practice. Our purpose is to show the efficacy of a new radiofrequency ablation (RFA) in combination with augmentation, using a percutaneous ablation device (Osteocool-Medtronic) in the treatment of secondary vertebral bone tumor, avoiding concurrent bias related to other treatments of the disease.

Detailed description

Only patient supposed to undergo percutaneous vertebral augmentation for secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled. Lesions to be treated must be metabolically active on Positronic Emission Computed Tomography (PET-CT), performed during the last month. Patients will be informed and sign and inform consent. Patients will be treated with Augmentation and Ablation (Osteocool-Medtronic). Post treatment patients will be submitted to a new PET-CT in order to verify activity on treated site.

Conditions

• Bone Cancer Metastatic
• Radiofrequency Ablation
• Spine Metastases
• Vertebral Metastasis

Interventions

Type	Name	Description
DEVICE	Radiofrequency Ablation and Bone Augmentation	Percutaneous Tumor Ablation of Spine Lesions followed by Polymer Augmentation

Timeline

• Start date: 2023-01-01
• Primary completion: 2028-06-01
• Completion: 2028-12-31
• First posted: 2024-12-04
• Last updated: 2026-04-09

Locations

1 site across 1 country: Greece