Effectiveness Of Radiofrequency Ablation And Stabilizatio... | NCT06716294

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

NCT06716294

Sponsor

National and Kapodistrian University of Athens

Status

Recruiting

Last Update Posted

Apr 9, 2026Actual

Enrollment

16Estimated

Phase

Not provided

Conditions

Bone Cancer Metastatic
Radiofrequency Ablation
Spine Metastases
Vertebral Metastasis

Interventions

Radiofrequency Ablation and Bone Augmentation

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jun 1, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Nov 29, 2024

First Submission Date that Met QC Criteria

Nov 29, 2024

First Posted Date

Dec 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2026

Last Update Posted Date

Apr 9, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexis Kelekis, PROFESSOR OF DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY, National and Kapodistrian University of AthensPrincipal Investigator

Lead Sponsor

National and Kapodistrian University of AthensOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiofrequency Ablation and Bone Augmentation	Device	Percutaneous Tumor Ablation of Spine Lesions followed by Polymer Augmentation		Vertebroplasty

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alexis Kelekis, MD PHD, EBIR	Contact	+302105831806		akelekis@med.uoa.gr
MARIA IOANNIDI, MD	Contact

Overall Officials

Name	Affiliation	Role
ALEXIOS KELEKIS, MD, PHD	National and Kapodistrian University of Athens	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
3rd Department of Radiology, NKUOA, General Hospital "LAIKON"	Recruiting	Athens	Athens	11527	Greece

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative
D060826	Cementoplasty
D019637	Orthopedic Procedures