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

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:

MedlinePlus related topics: MRI Scans

Drug Information available for: Gadobutrol

U.S. FDA Resources

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.

Estimated Enrollment:	50
Study Start Date:	May 2012
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 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

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

Contacts

Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')	(+)1-888-84 22937

Locations

United States, Georgia
	Terminated
Atlanta, Georgia, United States, 30342-1605
	Not yet recruiting
Savannah, Georgia, United States, 31406
United States, Illinois
	Recruiting
Chicago, Illinois, United States, 60611
United States, Massachusetts
	Recruiting
Boston, Massachusetts, United States, 02111
United States, New York
	Terminated
New York, New York, United States, 10032
United States, Ohio
	Recruiting
Cincinnati, Ohio, United States, 45229
United States, Texas
	Recruiting
Houston, Texas, United States, 77030
Canada, Alberta
	Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Germany
	Recruiting
Halle, Sachsen-Anhalt, Germany, 06097
	Recruiting
Dresden, Sachsen, Germany, 01307
	Recruiting
Jena, Thüringen, Germany, 07740

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT01544166 History of Changes
Other Study ID Numbers:	91741, 2010-023003-96
Study First Received:	February 28, 2012
Last Updated:	May 2, 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 May 23, 2013