Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
0–2
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)
