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

NCT ID: NCT06716294

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2028-12-31

Brief Summary

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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 radioablation (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

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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 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.

Conditions

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Bone Cancer Metastatic Radiofrequency Ablation Spine Metastases Vertebral Metastasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Radiofrequency Ablation and Bone Augmentation

Percutaneous Tumor Ablation of Spine Lesions followed by Polymer Augmentation

Intervention Type DEVICE

Other Intervention Names

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Vertebroplasty

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Alexis Kelekis

PROFESSOR OF DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ALEXIOS KELEKIS, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens, Greece

Locations

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Attikon General University Hospital

Athens, Haidari, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Alexis Kelekis, MD PHD, EBIR

Role: CONTACT

Phone: +302105831806

Email: [email protected]

MARIA IOANNIDI, MD

Role: CONTACT

Facility Contacts

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Alexis Kelekis

Role: primary

Other Identifiers

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46351/2020

Identifier Type: -

Identifier Source: org_study_id