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Recruiting NCT06716294

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

— Observational Bone Cancer Metastatic Radiofrequency Ablation Spine Metastases Vertebral Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiofrequency Ablation and Bone Augmentation.
Who it may be relevant to
Registry conditions: Bone Cancer Metastatic, Radiofrequency Ablation, Spine Metastases, Vertebral Metastasis. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Radiofrequency Ablation and Bone Augmentation
    Percutaneous Tumor Ablation of Spine Lesions followed by Polymer Augmentation

Primary outcome measures

  • PET-CT [Time frame: SUV measurement of PET in 24 hours]
Secondary outcome measures (1)
  • Greek Brief Pain Index (GBPI) [Time frame: 1 MONTH, 6 MONTHS, 12 MONTHS]

Eligibility criteria

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Greece · 1 center
  • 3rd Department of Radiology, NKUOA, General Hospital "LAIKON" — Athens

Identifiers

NCT: NCT06716294 · 46351/2020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗