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

April 6, 2026 updated by: Alexis Kelekis, National and Kapodistrian University of Athens

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: MARIA IOANNIDI, MD

Study Locations

  • Greece
    • Athens
      • Athens, Athens, Greece, 11527
        • Recruiting
        • 3rd Department of Radiology, NKUOA, General Hospital "LAIKON"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET-CT
Time Frame: SUV measurement of PET in 24 hours
Positron Emission Tomography (PET) Activity
SUV measurement of PET in 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Greek Brief Pain Index (GBPI)
Time Frame: 1 MONTH, 6 MONTHS, 12 MONTHS
NUMERIC VISUAL SCORE (NVS) OF PAIN AND MOBLITY
1 MONTH, 6 MONTHS, 12 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Investigators

  • Principal Investigator: ALEXIOS KELEKIS, MD, PHD, National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Actual)

December 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46351/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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