Status:
TERMINATED
Safety and Efficacy of MultiHance in Pediatric Patients
Lead Sponsor:
Bracco Diagnostics, Inc
Conditions:
Central Nervous System Diseases
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous syst...
Eligibility Criteria
Inclusion
- Between 2 and 17 years of age
- Informed consent from parents
- Assent from patient where required
- Known or highly suspected disease of the CNS and referred for either cranial or spinal MRI examination
Exclusion
- Contraindication to MRI
- Undergoing MRI in an emergency situation
- Known allergy to one or more of the ingredients in MultiHance
- Sickle cell anemia moderate to severe renal impairment
- Received another investigational compound within 30 days
- Pregnancy
- Lactating females
- Likely to undergo an invasive procedure within 72 hours of receiving MultiHance
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00323310
Start Date
April 1 2006
End Date
September 1 2008
Last Update
October 22 2010
Active Locations (1)
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1
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540