DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years
Condition: Magnetic Resonance Imaging
Intervention: DOTAREM
Intervention description: Single intravenous injection of 0.1 mmol/kg body weight
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Maximum age: 2 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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

        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