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NCT Number: NCT06716294

Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By Positron Emission Computed Tomography (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.

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Key information

Conditions

Bone Cancer Metastatic Radiofrequency Ablation Spine Metastases Vertebral Metastasis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Athens, 11527, Greece

Location status: Recruiting

Location contact

Alexis Kelekis, MD, PhD, EBIR

CONTACT

[email protected]

+302132061284

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Radiofrequency Ablation and Bone Augmentation

Device

Percutaneous Tumor Ablation of Spine Lesions followed by Polymer Augmentation

Other names: Vertebroplasty

Primary outcomes

  1. PET-CT

    Time frame: SUV measurement of PET in 24 hours

    Positron Emission Tomography (PET) Activity

Secondary outcomes

  1. Greek Brief Pain Index (GBPI)

    Time frame: 1 MONTH, 6 MONTHS, 12 MONTHS

    NUMERIC VISUAL SCORE (NVS) OF PAIN AND MOBLITY

Study contacts

Contact information is provided by the study sponsor or research team.

Alexis Kelekis, MD PHD, EBIR

CONTACT

[email protected]

+302105831806

MARIA IOANNIDI, MD

CONTACT

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

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

Acronym: ABLASPINE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 4, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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