Status:
COMPLETED
Contrast-enhanced MRI in Children 2 Months to <2 Years
Lead Sponsor:
Bayer
Conditions:
Magnetic Resonance Imaging
Eligibility:
All Genders
2-23 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to \< 2 years of age
Detailed Description
Safety issues are addressed in the AE section
Eligibility Criteria
Inclusion
- Age: 2 months to \< 2 years (23 months)
- Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI
- Able to comply with the study procedures
Exclusion
- Clinical unstable participants (eg, intensive care unit)
- Renal Insufficiency
- Participants undergoing chemotherapy \</= 48 hours prior to and up to 24 hours after the administration of Magnevist.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00937391
Start Date
January 1 2010
End Date
September 1 2010
Last Update
November 18 2015
Active Locations (13)
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1
San Diego, California, United States, 92123
2
Aurora, Colorado, United States, 80045
3
Chicago, Illinois, United States, 60614
4
Iowa City, Iowa, United States, 52242