At a glance
ClinicalIndex Comparison Record- ✓Age <2 years (term newborn infants to 23 months inclusive)
- ✓Scheduled to undergo routine gadolinium-enhanced MRI of any body region
- ✕Chemotherapy change within 48 hours prior to or 24 hours after gadobutrol injection
- ✕Any planned intervention during study and up to 24 hours after injection (excluding lumbar puncture)
- ✕Investigational product within 48 hours before injection or during study participation
- ✕Other contrast agent within 48 hours prior to or 24 hours after injection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Gadobutrol (Gadavist, BAY86-4875) for Magnetic Resonance Imaging. Completed, enrolled 44 participants across 9 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants \<2 years of age.