Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

Open-label, Multicenter, Pharmacokinetic, and Safety Study in Children (Term Newborn Infants to 23 Months of Age) Undergoing a Contrast-enhanced MRI With an Intravenous Injection of 0.1 mmol/kg BW Gadobutrol 1.0 M

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.

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