A Single-blind, Multicenter, Randomized, Phase III Study of the Efficacy and Safety of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent for Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions in Chinese Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 147
- 试验地点
- 4
- 主要终点
- Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions
研究概览
简要总结
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese origin, with known or suspected brain or spine diseases
排除标准
- •Pregnancy
- •Lactation
- •Conditions interfering with MRI
- •Allergy to any contrast agent or any drugs
- •Participation in other trial
- •Require emergency treatment
- •Severely impaired liver and kidney functions
研究组 & 干预措施
Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875)
Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
干预措施: Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Drug)
GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)
Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
干预措施: Magnevist (Drug)
结局指标
主要结局
Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions
时间窗: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
CNR = (signal intensity \[SI\] lesion - SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.
次要结局
- Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment(Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast))
- Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan(Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast))
- Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI(Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast))
- Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions(Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast))