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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Greece
3rd Department of Radiology, NKUOA, General Hospital LAIKON
RECRUITING
Athens
Contact Information
Primary
Alexis Kelekis, MD PHD, EBIR
akelekis@med.uoa.gr
+302105831806
Backup
MARIA IOANNIDI, MD
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 16
Related Therapeutic Areas
Sponsors
Leads: National and Kapodistrian University of Athens

This content was sourced from clinicaltrials.gov