DOTAREM® Pharmacokinetics, Safety and Efficacy Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

GUERBET0 个研究点目标入组 50 人开始时间: 2014年7月9日最近更新: 2016年1月25日

适应症

试验速览

暂无简介。

•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, - according to estimated glomerular filtration rate calculated based on the Schwartz formula
•Subject whose parents or legal guardian (where applicable) has/have provided his/her/their fully informed written consent for the participation of the child in the trial. Parents or guardian must have the ability to read, understand and willingness to sign the informed consent form
•Subject with health insurance, according to the local regulatory requirement
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 50
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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 known severe liver disease
•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 who received will receive any investigational product within 7 days before DOTAREM injection or during study participation
•Any condition which, based on the investigator's clinical judgement, would prevent the subject from participating in all study assessments and visits

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