Status:
COMPLETED
A Pharmacokinetics Study of MultiHance in Pediatric Patients
Lead Sponsor:
Bracco Diagnostics, Inc
Conditions:
Central Nervous System Pathology
Eligibility:
All Genders
2-5 years
Phase:
PHASE1
Brief Summary
Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults
Eligibility Criteria
Inclusion
- Male or female between 2 and 5 years of age
- Obtained informed consent from patient's parent or guardian
- Obtain assent when applicable according to local law
- Known or suspected disease of the central nervous system (brain or spine)
- Referred for MRI of the brain or spine requiring an injection of an MR contrast agent
Exclusion
- Contraindications to MR examination
- Undergoing MRI in an emergency situation
- Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals
- Sickle cell anemia
- Likely to undergo an invasive examination within 72 hours after administration of the investigational product
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00411931
Start Date
September 1 2006
End Date
December 1 2007
Last Update
January 11 2008
Active Locations (1)
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1
Krakow, Poland