Bone Cancer Metastatic, Radiofrequency Ablation, Spine Metastases, Vertebral Metastasis
Conditions
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.
Interventions
DEVICERadiofrequency Ablation and Bone Augmentation
Percutaneous Tumor Ablation of Spine Lesions followed by Polymer Augmentation
Sponsors
National and Kapodistrian University of Athens
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET-CT | SUV measurement of PET in 24 hours | Positron Emission Tomography (PET) Activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Greek Brief Pain Index (GBPI) | 1 MONTH, 6 MONTHS, 12 MONTHS | NUMERIC VISUAL SCORE (NVS) OF PAIN AND MOBLITY |
Countries
Greece
Contacts
CONTACTAlexis Kelekis, MD PHD, EBIR
CONTACTMARIA IOANNIDI, MD
PRINCIPAL_INVESTIGATORALEXIOS KELEKIS, MD, PHD
National and Kapodistrian University of Athens
Outcome results
None listed