Open-label, Multi-center, Two-stage, Age Stratified, Pharmacokinetic, Safety, and Efficacy Study in Children 2 Months to < 2 Years of Age Undergoing Magnevist Injection Enhanced MRI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 54
- 主要终点
- Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
研究概览
简要总结
The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to < 2 years of age
详细描述
Safety issues are addressed in the AE section
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 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 2 months to < 2 years (23 months)
- •Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI
- •Able to comply with the study procedures
排除标准
- •Clinical unstable participants (eg, intensive care unit)
- •Renal Insufficiency
- •Participants undergoing chemotherapy </= 48 hours prior to and up to 24 hours after the administration of Magnevist.
研究组 & 干预措施
Gadopentetate dimeglumine (Magnevist, BAY86-6661)
For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
干预措施: Gadopentetate dimeglumine (Magnevist, BAY86-6661) (Drug)
结局指标
主要结局
Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)
时间窗: Within 5 minutes after injection
A clinical judgment by the open-label Clinical Investigators (CIs) as to whether ("yes") or not ("no") the CI could make a diagnosis from the image.
Dose Determined by Blinded Readers to be Superior for Diagnosis
时间窗: Within 5 minutes after injection
Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters
Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers
时间窗: Within 5 minutes after injection
For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information. The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant. If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant. The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose.
PK Analysis - Total Clearance (CL)
时间窗: 20 to 45 min and 4 to 8 hours post injection
Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug.
PK Analysis - Total Clearance (CL)/Body Weight (BW)
时间窗: 20 to 45 min and 4 to 8 hours post injection
CL/BW = total clearance normalized by BW
PK Analysis - Volume of Distribution at Steady State (Vss)
时间窗: 20 to 45 min and 4 to 8 hours post injection
Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.
PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)
时间窗: 20 to 45 min and 4 to 8 hours post injection
Vss/BW = volume of distribution at steady state normalized by body weight
PK Analysis - Area Under the Drug Concentration-time Curve (AUC)
时间窗: Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.
AUC = Area under the drug concentration-time curve from administration to infinity
PK Analysis - t 1/2
时间窗: Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity
t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity
次要结局
- Number of Participants With Number of Lesions Detected - Stage 1(Within 5 minutes after injection)
- Number of Participants With Number of Lesions Detected - Stage 2(Within 5 minutes after injection)
- Number of Participants With Quality of Lesion Visualization - Stage 1(Within 5 minutes after injection)
- Number of Participants With Quality of Lesion Visualization - Stage 2(Within 5 minutes after injection)
- Number of Participants With Quality of Border Delineation - Stage 1(Within 5 minutes after injection)
- Number of Participants With Quality of Border Delineation - Stage 2(Within 5 minutes after injection)
- Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1(Within 5 minutes after injection)
- Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2(Within 5 minutes after injection)
- Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1(Within 5 minutes after injection)
- Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2(Within 5 minutes after injection)
- Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1(Within 5 minutes after injection)
- Number of Participants With Diagnostic Confidence - Stage 1(Within 5 minutes after injection)
- Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2(Within 5 minutes after injection)
- Number of Participants With Diagnostic Confidence - Stage 2(Within 5 minutes after injection)
- Management Based on Unenhanced Images - Stage 1(Within 5 minutes before injection)
- Management Based on Unenhanced Images - Stage 2(Within 5 minutes before injection)
- Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1(Within 5 minutes after injection)
- Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2(Within 5 minutes after injection)
- Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1(Within 5 minutes after injection)
- Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2(Within 5 minutes after injection)