NCT00764387已完成4 期
Contrast-enhanced MRI Examination of Cerebral Neoplastic Enhancing Lesions: Comparison of Diagnostic Efficacy of Gd-DOTA 0.5M and Gadobutrol 1.0 M at 0.1 mmol/kg Body Weight: Intraindividual Comparison Clinical Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 166
- 主要终点
- The primary analysis will be the comparison of the enhancements characteristics of Gadobutrol and Gd-TOTA on a lesion per lesion basis.
研究概览
简要总结
Study to compare of two contrast agents in imaging brain lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Known neoplastic CNS lesions
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Experimental
干预措施: Gadovist® (Gadobutrol, BAY86-4875) (Drug)
Arm 2
Active Comparator
干预措施: Dotarem (Drug)
结局指标
主要结局
The primary analysis will be the comparison of the enhancements characteristics of Gadobutrol and Gd-TOTA on a lesion per lesion basis.
时间窗: October 2007 to November 2008
次要结局
未报告次要终点
研究者
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Contrast-enhanced MRI examination of cerebral neoplastic enhancing lesions: comparison of diagnostic efficacy of Gd-DOTA 0.5 M and gadobutrol 1.0 M at 0.1 mmol Gd/kg body weight: Intra-individual comparison clinical study - NDEUCTR2007-005693-31-ITBAYER
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