Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)
Condition: Magnetic Resonance Imaging
Intervention: Gadobutrol (Gadavist, BAY86-4875)
Intervention description: Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Maximum age: 2 Years
Healthy volunteers: No
Keywords: Gadolinium, Pediatrics, MRI, contrast

Summary:

      The main purpose of this study is to collect data on the way gadobutrol is taken into, moves
      around, and is eliminated from, the body of children aged 0 to less than 2 years. The study
      will also evaluate safety and tolerability, and efficacy of gadobutrol.

      A maximum total amount of approximately 5 ml of blood will be needed for these analyses which
      will be drawn within 2-3 days.

      Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI),
      potentially allowing better visibility of tissues in the body. Children aged under 2 years
      scheduled for a routine contrast-enhanced MRI examination of any body region may take part in
      this study, in which case they will receive gadobutrol as contrast agent intravenously at the
      standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal
      insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate <80% of age
      adjusted normal value calculated based on the Schwartz formula) will be included in the
      trial.

      The duration of this study as a whole is around 1 year and the total number of children to be
      enrolled is 50. A child will be expected to take part in the study for around 7 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age
             inclusive)

          -  Subject is scheduled to undergo routine gadolinium-enhanced MRI of any body region

        Exclusion Criteria:

          -  Subjects undergoing a change in chemotherapy within 48 hours prior to and up to 24
             hours after gadobutrol injection

          -  Any planned intervention during the study and up to 24 hours after gadobutrol
             injection (excluding lumbar puncture)

          -  Subjects who received or will receive any investigational product within 48 hours
             before gadobutrol injection or during study participation

          -  Subjects who received or will receive any other contrast agent within 48 hours prior
             to gadobutrol injection or up to 24 hours after gadobutrol injection

          -  Subjects with contraindication for MRI such as iron metal implants (e.g. aneurysm
             clips)

          -  History of anaphylactoid or anaphylactic reaction to any allergen including drugs and
             contrast agents

          -  Subject with renal insufficiency of any intensity, i.e. estimated Glomerular
             Filtration Rate <80% of age adjusted normal value calculated based on the Schwartz
             formula