Study to evaluate the product flow, breakdown and elimination of DOTAREM from the blood and its safety and efficacy in children aged > 2 years

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

•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
•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

Exclusion Criteria

•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
•Any condition which, based on the investigator's clinical judgement, would prevent the subject from participating in all study assessments and visits

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials