Gadobutrol pharmacokinetic and safety study in pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive)

• Conditions: Pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive) scheduled to undergo routine gadolinium-enhanced MRI of any body region; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2010-023003-96-DE
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-24
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive) scheduled to undergo routine gadolinium-enhanced MRI of any body region
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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. eGFR <80% of age adjusted normal value calculated based on the Schwartz formula

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified