Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET-CT Confirmation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- PET-CT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
PET-CT
时间窗: SUV measurement of PET in 24 hours
Positron Emission Tomography (PET) Activity
PET
时间窗: SUV measurement of PET in 24 hours
PET ACTIVITY
次要结局
- Greek Brief Pain Index (GBPI)(1 MONTH, 6 MONTHS, 12 MONTHS)
- GBPI(1 MONTH, 6 MONTHS, 12 MONTHS)
研究者
Alexis Kelekis
PROFESSOR OF DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY
National and Kapodistrian University of Athens