Comparison of Cliavist Enhancement in Infectious and Degenerative Diseases of the Spine
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- First MRI: performed immediately after gadolinium administration
研究概览
简要总结
USPIO contrast enhancement results from intracellular trapping of the iron particles in reactive cells, especially macrophages. 17FDG-PET studies have demonstrated that macrophages are present in spine infectious diseases but are absent in spine degenerative diseases. The aim of this work is to compare the enhancement induced by CLIAVIST in both diseases. The absence of macrophages in degenerative lesions should help to differentiate them from infectious lesions, who should present contrast enhancement in relation to the presence of macrophages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •spine infection or spine degenerative disease
- •patient agreement obtained
排除标准
- •pregnancy
- •MRI contra-indications
- •cliavist contra-indication
- •dextran allergy
研究组 & 干预措施
Cliavist
干预措施: Cliavist (Drug)
结局指标
主要结局
First MRI: performed immediately after gadolinium administration
时间窗: immediately after gadolinium administration
Second MRI: performed 24 hours after cliavist administration
时间窗: 24 hours after cliavist administration
次要结局
未报告次要终点