Status:
COMPLETED
A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children
Lead Sponsor:
Bayer
Conditions:
Magnetic Resonance Imaging
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
Brief 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 mode...
Detailed Description
Please note that the present study is allocated two study phases, i.e. phase I and phase III.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00468819
Start Date
May 1 2007
End Date
April 1 2008
Last Update
July 22 2015
Active Locations (14)
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1
Vienna, Vienna, Austria, 1090
2
Edmonton, Alberta, Canada, T6G 2B7
3
Toronto, Ontario, Canada, M5G 1X8
4
Erlangen, Bavaria, Germany, 91054