NCT00411931已完成1 期
A Clinical Investigation of the Pharmacokinetics and Safety of MultiHance in Patients From 2-5 Years of Age Undergoing A Clinical Indicated MRI of the CNS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Assess the blood PK of Multihance in patients from 2 to 5 years of age
研究概览
简要总结
Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults
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
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 2 and 5 years of age
- •Obtained informed consent from patient's parent or guardian
- •Obtain assent when applicable according to local law
- •Known or suspected disease of the central nervous system (brain or spine)
- •Referred for MRI of the brain or spine requiring an injection of an MR contrast agent
排除标准
- •Contraindications to MR examination
- •Undergoing MRI in an emergency situation
- •Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals
- •Sickle cell anemia
- •Likely to undergo an invasive examination within 72 hours after administration of the investigational product
结局指标
主要结局
Assess the blood PK of Multihance in patients from 2 to 5 years of age
时间窗: up to 24 hours post dose
次要结局
- Evaluate the safety of Multihance in patients from 2 to 5 years of age(through 72 hours post dose)
研究者
研究点 (1)
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