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

NCT06716294 | Recruiting

• 1 other identifier: 46351/2020
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• PET-CT

  Positron Emission Tomography (PET) Activity

  SUV measurement of PET in 24 hours

Secondary Outcomes (1)

• Greek Brief Pain Index (GBPI)

  1 MONTH, 6 MONTHS, 12 MONTHS

Interventions

Radiofrequency Ablation and Bone Augmentation DEVICE

Percutaneous Tumor Ablation of Spine Lesions followed by Polymer Augmentation

Also known as: Vertebroplasty

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Sixteen (16) patients will be enorolled. * \- 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

3rd Department of Radiology, NKUOA, General Hospital "LAIKON"

Athens, Athens, 11527, Greece

RECRUITING

MeSH Terms

Interventions

Radiofrequency Ablation; Vertebroplasty

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Cementoplasty; Orthopedic Procedures

Study Officials

• ALEXIOS KELEKIS, MD, PHD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis Kelekis, MD PHD, EBIR

CONTACT

+302105831806; akelekis@med.uoa.gr

MARIA IOANNIDI, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR OF DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: January 1, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

GR (1)