Evaluating radiofrequency ablation and stabilization for metastatic spine lesions
Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET-CT Confirmation
National and Kapodistrian University of Athens · NCT06716294
This study is testing if a new treatment that combines radiofrequency ablation and stabilization can help people with certain types of spine tumors feel better by looking at changes in their lesions after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | National and Kapodistrian University of Athens (other) |
| Locations | 1 site (Athens, Athens) |
| Trial ID | NCT06716294 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to demonstrate the metabolic changes in spine lesions treated with a combination of radiofrequency ablation and augmentation. Patients with secondary osteolytic and mixed spine tumors, having one to three active lesions confirmed by PET-CT, will be enrolled. The treatment involves using a percutaneous ablation device (Osteocool-Medtronic) to target metabolically active lesions. Following treatment, patients will undergo a follow-up PET-CT to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are patients with secondary osteolytic and mixed spine tumors who have one to three active lesions confirmed by recent PET-CT.
Not a fit: Patients with non-metabolically active lesions or those with more than three active lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with metastatic spine lesions.
How similar studies have performed: While this approach is novel, similar studies have shown promise in using radiofrequency ablation for treating metastatic lesions.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Athens, Athens
- 3rd Department of Radiology, NKUOA, General Hospital "LAIKON" — Athens, Athens, Greece (RECRUITING)
Study contacts
- Principal investigator: ALEXIOS KELEKIS, MD, PHD — National and Kapodistrian University of Athens
- Study coordinator: Alexis Kelekis, MD PHD, EBIR
- Email: akelekis@med.uoa.gr
- Phone: +302105831806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bone Cancer Metastatic, Radiofrequency Ablation, Spine Metastases, Vertebral Metastasis