Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT01544166
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
2 Years
Study:
NCT01544166
Study Brief:
Protocol Section:
NCT01544166