jRCT2011230024已完成不适用
A multicenter, prospective, open-label study to evaluate the pharmacokinetics and safety of gadoquatrane in pediatric participants (from birth to <18 years) undergoing contrast-enhanced magnetic resonance imaging (CE-MRI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- AUC of gadoquatrane
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Diagnostic Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- No limit 至 18age old not（—）
- 性别
- All
入选标准
- •Participants from birth to <18 years of age at the time of signing the informed consent form.
- •Participants who have a clinical indication to undergo a CE-MRI for any clinical condition in any body region and who can undergo study procedures as per Investigator judgement.
- •Participants can be male or female (according to their reproductive organs and functions assigned by chromosomal complement).
- •Female contraception and barriers as well as pregnancy testing is required as appropriate for the age and sexual activity of pediatric participants and as required by local regulations.
- •The legal guardian(s) is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •When applicable by law for a participant, a legal guardian must be available to help the study-site personnel ensure follow up, accompany the participant to the study site on each assessment day, and consistently and consecutively be available to provide information on the participant during the scheduled study visits.
排除标准
- •Body weight <2500 g at screening and baseline
- •The medical condition and/or local allowance for maximum blood draw in the pediatric participant is not suitable for study procedures, including pharmacokinetics (PK) and safety blood draws, without compromising any expected clinical care/procedure need.
- •Acute kidney injury (i.e., acute renal failure).
- •Age-adjusted renal function is decreased (eGFR <80% of age adjusted normal renal function) as evaluated by the investigator based on a serum creatinine result obtained within 2 weeks prior to study intervention.
- •Considered clinically unstable or has a concurrent/concomitant condition that may not allow participation for the full planned study period, in the judgement of the investigator.
- •History of moderate to severe allergic-like reaction to any GBCA.
- •Bronchial asthma considered unstable or had major therapeutical modification within last 4 weeks.
- •Severe cardiovascular disease, except for cardiac or vascular magnetic resonance (MR), if considered clinically justified by the investigator.
- •Planned or expected intervention (e.g., treatment or procedure) or change in treatment (e.g. start of chemotherapy) that may significantly affect study parameters (i.e. safety/adverse events [AEs] [e.g. confounding AEs or safety events due to surgery or chemotherapy], PK parameters) or would prevent the participant from performing study procedures, from the administration of gadoquatrane up to the 24 h +- 4 h follow-up.
- •Participants who received or will receive any other contrast agent within 72 hours prior to gadoquatrane injection or up to 72 hours after gadoquatrane injection.
- •Contraindications to the administration of GBCAs (depending on local product label), or history of adverse reaction to GBCAs.
结局指标
主要结局
AUC of gadoquatrane
时间窗: after single administration
Area under the curve (AUC) of gadoquatrane after single administration
CL/BW of gadoquatrane
时间窗: after single administration
Plasma clearance normalized to body weight (CL/BW) of gadoquatrane after single administration
Vss/BW of BAY1747846
时间窗: after single administration
Apparent volume of distribution at steady state normalized to body weight (Vss/BW) of BAY1747846 after single administration
C20
时间窗: 20 min post-injection
Simulation of plasma concentration at 20 min post-injection (C20)
次要结局
未报告次要终点
研究者
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