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Sponsors and Collaborators: |
Bayer Ecron |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00468819 |
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 Schering Pharma AG has developed a contrast agent for MRI called Gadovist® 1.0 which was first approved in 1998 in Switzerland. Since 2003 Gadovist® 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. Gadovist® 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 Gadovist® 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 Gadovist® 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 Gadovist® 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.
Condition | Intervention | Phase |
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Angiography |
Drug: Gadovist (BAY86-4875) |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | 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. |
Enrollment: | 138 |
Study Start Date: | May 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Gadovist (BAY86-4875)
In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.0 1 Days Injection |
Please note that the present study is allocated two study phases, i.e. phase I and phase III.
Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Wien, Austria, 1090 | |
Canada, Alberta | |
Edmonton, Alberta, Canada, T6G 2B7 | |
Canada, Ontario | |
Toronto, Ontario, Canada, M5G 1X8 | |
Denmark | |
Aarhus N, Denmark, 8200 | |
Germany, Bayern / 280 | |
Erlangen, Bayern / 280, Germany, 91054 | |
Germany, Nordrhein-Westfalen / 321 | |
Bonn, Nordrhein-Westfalen / 321, Germany, 53105 | |
Germany, Sachsen / 313 | |
Dresden, Sachsen / 313, Germany, 01307 | |
Leipzig, Sachsen / 313, Germany, 04103 | |
Germany, Sachsen-Anhalt / 311 | |
Halle, Sachsen-Anhalt / 311, Germany, 06097 | |
Germany, Schleswig-Holstein / 306 | |
Kiel, Schleswig-Holstein / 306, Germany, 24103 | |
Kiel, Schleswig-Holstein / 306, Germany, 24105 | |
Germany, Thüringen / 310 | |
Jena, Thüringen / 310, Germany, 07740 | |
Sweden | |
Stockholm, Sweden, 17176 | |
Göteborg, Sweden, 41485 | |
Uppsala, Sweden, 75185 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 91552, EudraCT 2006-004153-22, 310788 |
Study First Received: | May 2, 2007 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00468819 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Austria: Agency for Health and Food Safety; Canada: Health Canada |
Contrast-enhanced MRI MR angiography (MRA) Children 2-17 years |