A Single-blind, Intra-individual, Crossover, Multicenter Study of the Efficacy, Safety and Tolerability of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent in the Enhanced Magnetic Resonance Angiography (MRA) in Chinese Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 83
- 主要终点
- Number of Vessel Segments Visualized With Diagnostic Quality
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 vascular 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
- Crossover
- 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
- •Known or suspected blood vessel 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, then Gadopentate dimeglumine
Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged
干预措施: Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Drug)
Gadobutrol, then Gadopentate dimeglumine
Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged
干预措施: Gadopentate dimeglumine (Magnevist, BAY86-4882) (Drug)
Gadopentate, dimeglumine then Gadobutrol
Period 1: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged; Period 2: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged
干预措施: Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Drug)
Gadopentate, dimeglumine then Gadobutrol
Period 1: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged; Period 2: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged
干预措施: Gadopentate dimeglumine (Magnevist, BAY86-4882) (Drug)
结局指标
主要结局
Number of Vessel Segments Visualized With Diagnostic Quality
时间窗: 20-30 seconds after injection
Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.
次要结局
- MRA Diagnosis by Blinded Reader 1(20-30 seconds after injection)
- Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3(immediately before and 20-30 seconds after injection (precontrast and postcontrast))
- Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator(immediately before and 20-30 seconds after injection (precontrast and postcontrast))
- Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1(immediately before and 20-30 seconds after injection (precontrast and postcontrast))
- Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2(immediately before and 20-30 seconds after injection (precontrast and postcontrast))
- MRA Diagnosis by Investigators(20-30 seconds after injection)
- MRA Diagnosis by Blinded Reader 2(20-30 seconds after injection)
- MRA Diagnosis by Blinded Reader 3(20-30 seconds after injection)