RecruitingNCT06716294

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

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


Sponsor

National and Kapodistrian University of Athens

Enrollment

16 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria4

  • 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 Criteria1

  • \-

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Interventions

DEVICERadiofrequency Ablation and Bone Augmentation

Percutaneous Tumor Ablation of Spine Lesions followed by Polymer Augmentation


Locations(1)

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

Athens, Athens, Greece

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NCT06716294


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