Open-label multi-center study of magnetic resonance imaging (MRI) with 0.1 mmol/kg BW Gadovist (1.0 M) to assess pharmacokinetics, safety and tolerability in children

Bayer AB, Bayer Health Care, Bayer Schering Pharma0 sites140 target enrollmentMarch 7, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gadovist as diagnostic imaging agent is approved only for adult patients. Diseases usually representing indications for contrast-enhanced Magnetic Resonance Imaging (CE-MRI) are common also in a pediatric population. This study is a clinical routinely study in pediatric patients (male/ female) aged 2-17 years (3 age groups: 2-6, 7-11, and 12-17 years) who are scheduled to undergo Gd-enhanced MRI of brain, spine, liver and/or kidneys or Gd-enhanced MRA (single field of view).
Sponsor: Bayer AB, Bayer Health Care, Bayer Schering Pharma
Enrollment: 140
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

March 7, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Bayer AB, Bayer Health Care, Bayer Schering Pharma

•Patients must fulfill the following inclusion criteria:
•1\.1\.Patient is of specific age group, i.e.
•Age group I: 2 \- 6 years
•Age group II: 7 \- 11 years
•Age group III: 12 \- 17 years
•2\. Patient is scheduled to undergo routine Gd\-enhanced MRI of brain, spine, liver and/or kidneys or Gd\-enhanced MRA (single field of view only)
•3\. Patient is able and willing to undergo the study MRI/MRA procedure with Gadovist
•4\. Patient is willing to comply with the study procedures (e.g. being followed\-up for 24 (\+/\- 4\) hours after the Gadovist injection)
•5\. Fully informed written consent of parent(s)/ legal representative(s)
•6\. Following informed consent by parent(s)/ legal representative(s), assent (as regarded as appropriate according to the opinion of the pediatrician and/or investigator) for active study participation is obtained based on age\-appropriate trial information.

•Patients are to be excluded from the study if they meet any of the following exclusion criteria:
•1\. Clinically unstable patient, e.g. patient in whom fluctuations in safety parameters may be observed during the study period due to underlying disease and/or respective treatment regiments (e.g. polytrauma patients, intensive care unit)
•2\. Patient undergoing a change in chemotherapy \= 48 hours prior to and up to 24 hours after administration of Gadovist
•3\. Any planned intervention during the study and up to 24 hours after administration of Gadovist
•4\. Patient who has received or will receive any investigational drug 48 hours before MR\-examination or during study participation.
•5\. Patient having received any other contrast agent within 30 hours prior to injection of Gadovist or likely to receive one during the 24\-hour follow\-up period
•6\. Patient presenting with contraindication for MRI, e.g. pacemaker, iron metal implants (e.g. aneurysm clips) or severe claustrophobia
•7\. Patient presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
•8\. Severe inborn or acquired heart rhythm anomalies
•9\. Congenital long QT syndrome or family history of congenital long QT syndrome