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

Recruiting

• Conditions: Bone Cancer Metastatic; Radiofrequency Ablation; Spine Metastases; Vertebral Metastasis

• Registration Number: NCT06716294
• Lead Sponsor: National and Kapodistrian University of Athens

Brief 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 radioablation (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 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.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-06-01
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• only patients with 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 PET-CT performed during the last month.
• Patients will be informed and sould sign an inform consent.
• post treatment patients should submittes a new PET-CT in order to verify the activity of the treated area.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PET	SUV measurement of PET in 24 hours	PET ACTIVITY

Secondary Outcome Measures

Name	Time	Method
GBPI	1 MONTH, 6 MONTHS, 12 MONTHS	NVS SCORE OF PAIN AND MOBLITY

Trial Locations

Locations (1)

Attikon General University Hospital; 🇬🇷 Athens, Haidari, Greece