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

National and Kapodistrian University of Athens

Status: Enrolling

Conditions: Vertebral Metastasis; Bone Cancer Metastatic; Radiofrequency Ablation; Spine Metastases

Treatments: Device: Radiofrequency Ablation and Bone Augmentation

Study type: Observational

Funder types: Other

Identifiers

NCT06716294

46351/2020

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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