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 Schering Pharma0 个研究点目标入组 140 人2007年4月23日

概览

暂无简介。

注册库

who.int

开始日期

2007年4月23日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

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.
•Are the trial subjects under 18? yes

•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