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Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

NCT01544166 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-12-16

Study results available
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Summary

The main purpose of this study is to collect data on the way gadobutrol is taken into, moves around, and is eliminated from, the body of children aged 0 to less than 2 years. The study will also evaluate safety and tolerability, and efficacy of gadobutrol.

A maximum total amount of approximately 5 ml of blood will be needed for these analyses which will be drawn within 2-3 days.

Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI), potentially allowing better visibility of tissues in the body. Children aged under 2 years scheduled for a routine contrast-enhanced MRI examination of any body region may take part in this study, in which case they will receive gadobutrol as contrast agent intravenously at the standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate \<80% of age adjusted normal value calculated based on the Schwartz formula) will be included in the trial.

The duration of this study as a whole is around 1 year and the total number of children to be enrolled is 50. A child will be expected to take part in the study for around 7 days.

Conditions

  • Magnetic Resonance Imaging

Interventions

DRUG

Gadobutrol (Gadavist, BAY86-4875)

Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants \<2 years of age.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-16
Primary Completion
2013-11-28
Completion
2013-11-28

Countries

  • United States
  • Canada
  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01544166 on ClinicalTrials.gov