DOTAREM® Pharmacokinetics, Safety and Efficacy Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 51
- 试验地点
- 9
- 主要终点
- Rate Constant of the Terminal Phase of DOTAREM
研究概览
简要总结
The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of children aged less than 2 years thanks to several blood samples (3 ml in total) taken following the administration of DOTAREM®.
DOTAREM® is a contrast agent commonly used for enhancement of Magnetic Resonance Imaging (MRI) to potentially improve the quality of the images and help the diagnosis. Children aged less than 2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region may take part in the study. In this case they will receive DOTAREM®, a solution injected at the standard dose of 0.2mL/kg (0.1 mmol/kg) of body weight.
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
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric subject aged <2 years (term newborn infants to toddlers 23 months of age inclusive). Term is defined as ≥37 weeks of amenorrhea
- •Subject is scheduled to undergo routine gadolinium-enhanced MRI of any body region (e.g. CNS, cardiac) at the dose of 0.1 mmol/kg BW (0.2 mL/kg BW)
- •Subject with normal renal function for its age, estimated glomerular filtration rate calculated based on the Schwartz formula
排除标准
- •Subject planned for intervention (e.g. surgery) between the screening visit and up to 24 hours after DOTAREM injection
- •Subject whose preceding or subsequent treatment to DOTAREM injection (e.g., blood loss or receiving blood, treatment with diuretics, etc...) would alter DOTAREM pharmacokinetics parameters
- •Subject with subsequent planned treatment after DOTAREM injection that would prevent obtaining the required blood samples (e.g., emergency surgery, etc...)
- •Subject with a history of a bleeding disorder
- •Subject with severe liver disease (Child's Pugh Classification B or greater or serum direct bilirubin greater than 0.3 mg/dL, age adjusted)
- •Subject with electrolyte or fluid imbalance that presents undue risk
- •Subject undergoing a change in chemotherapy within 48 hours prior to and up to 24 hours after DOTAREM injection
- •Subject who received or will receive any other contrast agent within 72 hours prior to DOTAREM injection or up to 24 hours after DOTAREM injection
- •Subject with contraindication for MRI such as iron metal implants (e.g. aneurysm clips)
- •Subject with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
- •Subject having participated within 30 days in a clinical study involving an investigational drug or device
- •Subject planned to participate simultaneously to another clinical study
研究组 & 干预措施
DOTAREM
干预措施: DOTAREM (Drug)
结局指标
主要结局
Rate Constant of the Terminal Phase of DOTAREM
时间窗: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection
Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Rate constant of the terminal phase was determined from typical and individual DOTAREM concentration-time profiles.
Total Clearance of DOTAREM From Plasma
时间窗: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection
Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Total clearance was determined from typical and individual DOTAREM concentration-time profiles.
Area Under the Curve of DOTAREM in Plasma
时间窗: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection
Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Area under the curve was determined from typical and individual DOTAREM concentration-time profiles.
Terminal Elimination Half-life of DOTAREM From Plasma
时间窗: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection
Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Terminal elimination half-life was determined from typical and individual DOTAREM concentration-time profiles.
Volume of Distribution of DOTAREM at Steady State
时间窗: Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection
Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Volume of distribution at steady state was determined from typical and individual DOTAREM concentration-time profiles.
次要结局
- Simulated Plasma Concentration of DOTAREM(at 10 and 20 min post-injection)
- MRI Lesion Visualization at Subject Level(Pre-injection and post-injection (estimated between 5 and 20 minutes after injection))