NCT06716294 Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By Positron Emission Computed Tomography (PET-CT) Confirmation
| NCT ID | NCT06716294 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National and Kapodistrian University of Athens |
| Condition | Bone Cancer Metastatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 16 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 16 participants in total. It began in 2023-01-01 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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: \-
Contact & Investigator
ALEXIOS KELEKIS, MD, PHD
PRINCIPAL INVESTIGATOR
National and Kapodistrian University of Athens
Frequently Asked Questions
Who can join the NCT06716294 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Bone Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06716294 currently recruiting?
Yes, NCT06716294 is actively recruiting participants. Contact the research team at akelekis@med.uoa.gr for enrollment information.
Where is the NCT06716294 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT06716294 clinical trial?
NCT06716294 is sponsored by National and Kapodistrian University of Athens. The principal investigator is ALEXIOS KELEKIS, MD, PHD at National and Kapodistrian University of Athens. The trial plans to enroll 16 participants.
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