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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01544166
First received: February 28, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Magnetic Resonance Imaging
Drug: Gadobutrol (Gadavist, BAY86-4875)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Typical area under the curve (AUC) of gadobutrol in plasma [ Time Frame: 3 time windows as 15 min to 60 min, 2 hours to 4 hours, and 6 hours to 8 hours post-injection ] [ Designated as safety issue: Yes ]
  • Individual area under the curve (AUC) of Gadobutrol in plasma [ Time Frame: 3 time windows as 15 min to 60 min, 2 hours to 4 hours, and 6 hours to 8 hours post-injection ] [ Designated as safety issue: Yes ]
  • Simulation of plasma concentration of Gadobutrol at 20 minutes post-injection [ Time Frame: 3 time windows as 15 min to 60 min, 2 hours to 4 hours, and 6 hours to 8 hours post-injection ] [ Designated as safety issue: No ]
  • Total body clearance of Gadobutrol from plasma [ Time Frame: 3 time windows as 15 min to 60 min, 2 hours to 4 hours, and 6 hours to 8 hours post-injection ] [ Designated as safety issue: No ]
  • Apparent volume of distribution of Gadobutrol at steady state [ Time Frame: 3 time windows as 15 min to 60 min, 2 hours to 4 hours, and 6 hours to 8 hours post-injection ] [ Designated as safety issue: No ]
  • Terminal elimination half-life of Gadobutrol [ Time Frame: 3 time windows as 15 min to 60 min, 2 hours to 4 hours, and 6 hours to 8 hours post-injection ] [ Designated as safety issue: No ]
  • Mean residence time of Gadobutrol [ Time Frame: 3 time windows as 15 min to 60 min, 2 hours to 4 hours, and 6 hours to 8 hours post-injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events collection [ Time Frame: From baseline to approximately 7 days after injection ] [ Designated as safety issue: Yes ]
  • Quality of Gadobutrol-enhanced magnetic resonance images as assessed by investigator [ Time Frame: Pre-injection, and immediately post-injection (as defined by investigator based on clinical need, estimated between 1 and 15 minutes post injection) ] [ Designated as safety issue: No ]
    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.


Enrollment: 44
Study Start Date: May 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Gadobutrol (Gadavist, BAY86-4875)
Single intravenous injection of 0.1 mmol/kg of body weight

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544166

Locations
United States, Georgia
Atlanta, Georgia, United States, 30342-1605
Savannah, Georgia, United States, 31406
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, New York
New York, New York, United States, 10032
United States, Ohio
Cincinnati, Ohio, United States, 45229
United States, Texas
Houston, Texas, United States, 77030
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Germany
Halle, Sachsen-Anhalt, Germany, 06097
Dresden, Sachsen, Germany, 01307
Jena, Thüringen, Germany, 07740
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01544166     History of Changes
Other Study ID Numbers: 91741, 2010-023003-96
Study First Received: February 28, 2012
Last Updated: December 18, 2013
Health Authority: Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by Bayer:
Gadolinium, Pediatrics, MRI, contrast

ClinicalTrials.gov processed this record on July 26, 2014