Trial Condition(s):

Magnetic Resonance Imaging

A study of magnetic resonance imaging (MRI) with Gadavist in children

Bayer Identifier:

91552

ClinicalTrials.gov Identifier:

NCT00468819

EudraCT Number:

2006-004153-22

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Patients (male/ female) of specific age groups (2-6 years, 7-11 years, 12-17 years) who are scheduled to undergo Gadolinium (Gd)-enhanced MRI of brain, spine, liver and/or kidneys or Gd-enhanced MRA (single field of view).
Exclusion Criteria
- Clinically unstable patients (e.g. intensive care unit)
 - Renal insufficiency
 - Patients undergoing a relevant change in chemotherapy </= 48 hours prior to and up to 24 hours after the administration of Gadovist.

Trial Summary

Enrollment Goal
140
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

Status
Completed
 
Locations

Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

Status
Completed
 
Locations

Hospital for Sick Children

Toronto, Canada, M5G 1X8

Status
Completed
 
Locations

University of Alberta Hospital

Edmonton, Canada, T6G 2B7

Status
Completed
 
Locations

Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

Status
Completed
 
Locations

Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg

Halle, Germany, 06120

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Klinikum der Friedrich-Schiller-Universität Jena

Jena, Germany, 07740

Status
Completed
 
Locations

Universität Erlangen-Nürnberg

Erlangen, Germany, 91054

Status
Completed
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

Karolinska Universitetsjukhuset, Astrid Lindgren Barnsjukhus

Stockholm, Sweden, 17176

Status
Completed
 
Locations

Drottning Silvias Barnoch ungdomssjukhus

Göteborg, Sweden, 41485

Status
Completed
 
Locations

Akademiska Sjukhuset

Uppsala, Sweden, 75185

Status
Completed
 
Locations

Gesundheitszentrum Kieler Mitte

Kiel, Germany, 24103

Status
Completed
 

Trial Design