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

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 (Gadovist 1.0)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023003-96-DE

Enrollment

Registered

2012-01-24

Start date

2012-04-25

Completion date

Unknown

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Gadovist® 1.0 mmol/ml, solution for injection Product Name: Gadovist® 1.0 mmol/ml, solution for injection Product Code: BAY 86-4875 Pharmaceutical Form: Solution for injection INN or Propo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pediatric subjects aged =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): 1) Adverse event collection 2) Quality of Gadobutrol-enhanced magnetic resonance images as assessed by investigator; Key quality aspects assessed by investigators will include Contrast Quality, Degree of contrast-enhancement in lesion or vessel, Border delineation of lesion or vessel, Visualization of lesion-internal morphology. ;Timepoint(s) of evaluation of this end point: 1) From baseline to approximately 7 days after injection of gadobutrol 2) Pre-injection, and immediately post-injection (as defined by investigator based on clinical need, estimated between 1 and 15 minutes post injection)	—

Measure

Time frame

Secondary end point(s): 1) Adverse event collection 2) Quality of Gadobutrol-enhanced magnetic resonance images as assessed by investigator; Key quality aspects assessed by investigators will include Contrast Quality, Degree of contrast-enhancement in lesion or vessel, Border delineation of lesion or vessel, Visualization of lesion-internal morphology. ;Timepoint(s) of evaluation of this end point: 1) From baseline to approximately 7 days after injection of gadobutrol 2) Pre-injection, and immediately post-injection (as defined by investigator based on clinical need, estimated between 1 and 15 minutes post injection)

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Primary

Measure	Time frame
Main Objective: To evaluate the pharmacokinetics of gadobutrol in plasma at the standard dose of 0.1 mmol/kg body weight in pediatric subjects aged <2 years. ;Secondary Objective: To evaluate safety and tolerability of gadobutrol at the standard dose of 0.1 mmol/kg BW in pediatric subjects aged <2 years. To evaluate qualitatively gadobutrol-enhanced images at the standard dose of 0.1 mmol/kg BW in pediatric subjects aged <2 years following MRI for any indication. To estimate the glomerular filtration rate prior to injection of gadobutrol, based on the Schwartz formula. ;Primary end point(s): 1)To evaluate the typical and individual area under the curve (AUC) of gadobutrol in plasma 2)To evaluate the simulation of plasma concentration 20 minutes post-injection of gadobutrol 3) Total body clearance of Gadobutrol from plasma 4) Apparent volume of distribution of Gadobutrol at steady state 5) Terminal elimination half-life of Gadobutrol 6) Mean residence time of Gadobutrol;Timepoint(s) of evaluation of this end point: Multiple time points within 8 hours post-injection	—

Measure

Time frame

Main Objective: To evaluate the pharmacokinetics of gadobutrol in plasma at the standard dose of 0.1 mmol/kg body weight in pediatric subjects aged <2 years. ;Secondary Objective: To evaluate safety and tolerability of gadobutrol at the standard dose of 0.1 mmol/kg BW in pediatric subjects aged <2 years. To evaluate qualitatively gadobutrol-enhanced images at the standard dose of 0.1 mmol/kg BW in pediatric subjects aged <2 years following MRI for any indication. To estimate the glomerular filtration rate prior to injection of gadobutrol, based on the Schwartz formula. ;Primary end point(s): 1)To evaluate the typical and individual area under the curve (AUC) of gadobutrol in plasma 2)To evaluate the simulation of plasma concentration 20 minutes post-injection of gadobutrol 3) Total body clearance of Gadobutrol from plasma 4) Apparent volume of distribution of Gadobutrol at steady state 5) Terminal elimination half-life of Gadobutrol 6) Mean residence time of Gadobutrol;Timepoint(s) of evaluation of this end point: Multiple time points within 8 hours post-injection

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Countries

Canada, Germany, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer HealthCare AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026