A Pharmacokinetics Study of MultiHance in Pediatric Patients
Phase 1
Completed
- Conditions
- Central Nervous System Pathology
- Registration Number
- NCT00411931
- Lead Sponsor
- Bracco Diagnostics, Inc
- Brief Summary
Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- 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
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assess the blood PK of Multihance in patients from 2 to 5 years of age up to 24 hours post dose
- Secondary Outcome Measures
Name Time Method Evaluate the safety of Multihance in patients from 2 to 5 years of age through 72 hours post dose