A Multicenter, Open-label, Phase III Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 223
- 主要终点
- Scores for visualization parameter: border delineation
研究概览
简要总结
Purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Subjects referred for a contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system based on current clinical symptoms or results of a previous imaging procedure
排除标准
- •Subjects with any contraindication to the MRI examination
- •Subjects with severe renal disease to end stage renal disease
- •Subjects scheduled or are likely to require a biopsy or any interventional therapeutic procedure within 72 (±4) hours after the study MRI
研究组 & 干预措施
Arm 1
干预措施: Gadobutrol (Gadovist, BAY86-4875) (Drug)
结局指标
主要结局
Scores for visualization parameter: border delineation
时间窗: Day of gadobutrol injection (Day 0)
Blinded readers evaluate border delineation of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.
Scores for visualization parameter: internal morphology
时间窗: Day of gadobutrol injection (Day 0)
Blinded readers evaluate internal morphology of at maximum 5 lesions and 4 normal structures in scans taken with and without gadobutrol on a 3-point-scale.
Scores for visualization parameter: degree of contrast enhancement
时间窗: Day of gadobutrol injection (Day 0)
Blinded readers evaluate contrast of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.
Number of detected lesions
时间窗: Day of gadobutrol injection (Day 0)
Blinded readers determine number of detected lesions in scans with and without gadobutrol.
次要结局
- Percentage of exact match of the MRI diagnosis with the final clinical diagnosis(Day of gadobutrol injection (Day 0))
- Sensitivity and specificity to detect abnormal/normal brain tissue(Day of gadobutrol injection (Day 0))
- Number of participants with treatment emergent adverse events as a measure of safety and tolerability(3 days after injection (Day 3))
- Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions(Day of gadobutrol injection (Day 0))