The Safety and Efficacy of MULTIHANCE at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients Who Are Less Than 2 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Visualization of internal morphology of lesions
研究概览
简要总结
Collection of already existing data and images for patients < 2 years of age having MultiHance administration for a MRI of the brain or spine. MR Images will be reviewed during a prospectively designed blinded reading of the images.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female less than 2 years of age at the time of the MRI with MultiHance injection at a dose of 0.1 mmol/kg (± 25% in volume administered)
- •Has available demographic and safety data
- •Has documented known or highly suspected enhancing disease of the CNS (brain/spine) and previously underwent a cranial or spinal MR examination requiring an injection of MULTIHANCE contrast agent
- •Has both pre and post dose T1 SE/FSE and/or GRE and T2 SE/FSE, and FLAIR MR images (when available) for submission to sponsor or designee to be evaluated in a fully blinded read
- •Has a documented dose of MultiHance administered for their MRI exam and/or volume (mL) and weight of the patient available to be used to calculate the dose of MultiHance that was administered
排除标准
- •Any patient who does not fulfill all of the inclusion criteria
结局指标
主要结局
Visualization of internal morphology of lesions
时间窗: Immediately post dose - Day 1
Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of visualization of internal morphology of the lesion(s)
Border delineation of lesions
时间窗: Immediately post dose - Day 1
Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of lesion border delineation
Contrast enhancement of lesions
时间窗: Immediately post dose- Day 1
Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of contrast enhancement of lesions
次要结局
未报告次要终点