Gadolinium Contrast Agent Gadobutrol Studied in Infants Under Age 2 for MRI Safety
A Phase 1 trial examines how gadobutrol moves through and exits the bodies of newborns and toddlers undergoing routine contrast MRI.
Summary
This Phase 1 clinical trial enrolled up to 50 children aged newborn to 23 months to study how gadobutrol, a gadolinium-based MRI contrast agent, behaves pharmacokinetically in very young patients. Children already scheduled for routine contrast-enhanced MRI received a standard intravenous dose of 0.1 mmol per kilogram body weight. Researchers collected small blood samples over two to three days and followed each child for approximately seven days to assess how the drug was absorbed, distributed, and eliminated. Only children with normal kidney function were included, given that gadolinium agents are cleared renally. The study also evaluated safety and tolerability. Sponsored by Bayer, it was completed within roughly one year. Understanding how contrast agents behave in infants is clinically important because pediatric pharmacokinetics differ meaningfully from adults, and dosing guidelines for this vulnerable age group require dedicated evidence.
Detailed Summary
Gadolinium-based contrast agents like gadobutrol are routinely used in MRI to improve tissue visibility, but their pharmacokinetic behavior in very young children — particularly those under two years of age — has historically been extrapolated from adult data. This Phase 1 trial was designed specifically to close that evidence gap by characterizing how gadobutrol is absorbed, distributed, and eliminated in infants and toddlers.
The study enrolled up to 50 children ranging from term newborns to toddlers 23 months old who were already scheduled to undergo clinically indicated contrast-enhanced MRI. Each child received gadobutrol intravenously at the standard dose of 0.1 mmol per kilogram body weight — the same dose used in older populations. Blood samples totaling no more than 5 ml were drawn over two to three days to capture pharmacokinetic data, and children were followed for approximately seven days to monitor safety and tolerability.
Children with any degree of renal insufficiency, defined as an estimated glomerular filtration rate below 80 percent of age-adjusted normal values using the Schwartz formula, were excluded. This exclusion reflects the known renal clearance pathway of gadolinium agents and the elevated risk of nephrogenic systemic fibrosis in renally impaired patients.
Because infants have immature renal function, different body water compartments, and distinct protein binding characteristics compared to adults and older children, dedicated pharmacokinetic data are essential for safe dosing. Findings from this trial would support evidence-based labeling for gadobutrol in the youngest patient population and help clinicians make informed decisions about contrast use in pediatric imaging.
While the trial has been completed, full results are not available from the abstract alone. The study represents an important regulatory and clinical step toward ensuring contrast-enhanced MRI can be performed safely and effectively in infants, a population with unique and undercharacterized drug metabolism profiles.
Key Findings
- Phase 1 trial evaluated gadobutrol pharmacokinetics in 50 infants and toddlers under 24 months old.
- Standard adult dose of 0.1 mmol/kg was administered to evaluate whether it is appropriate for very young children.
- Only children with normal kidney function were enrolled, reflecting gadolinium's renal clearance pathway.
- Minimal blood volume (under 5 ml) was used for sampling, minimizing burden on small pediatric patients.
- Study aimed to generate data needed for evidence-based dosing guidelines in the youngest MRI patients.
Methodology
This was a Phase 1, open-label pharmacokinetic and safety study sponsored by Bayer, enrolling up to 50 pediatric subjects from newborn to 23 months. Gadobutrol was administered intravenously at 0.1 mmol/kg during clinically scheduled MRI; serial blood sampling was performed over 2–3 days with a total follow-up of approximately 7 days per subject.
Study Limitations
The full results are not publicly available; this summary is based on the abstract only. The small sample size of 50 subjects limits statistical power and generalizability. Exclusion of renally impaired infants means findings do not address the highest-risk subgroup.
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