A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
Summary
In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has
already been approved for application in adults, will be investigated in children and
adolescents. MRI is a modern and safe examination method without delivering radiation burden
using magnetic fields to produce cross-sectional images of the human body. A special computer
program then puts these images together and creates a two or three-dimensional image of the
inner organs thus facilitating the detection and evaluation of pathological changes. In
contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the
examination which results in a stronger contrast in the examined area. Therefore,
pathological changes can be more easily detected and evaluated compared to non-enhanced MRI.
The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called
Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine.
Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e.
in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney
disease. Gadavist was examined in more than 2,900 adults within the framework of clinical
studies during development and has been used after its marketing authorization in meanwhile
more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only
conducted with adults so far. Diseases requiring MRI examinations, however, often occur in
children, too. Therefore, many contrast agents are already used on a regular basis in MRI
examinations of children, some of these contrast agents being authorized already. Within the
framework of this study the pharmacokinetic characteristics of Gadavist in children or
adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in
the body. In addition, safety and tolerability will be evaluated in order to demonstrate that
Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents.
Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body
weight also for this population group.