Safety and Efficacy of MultiHance in Pediatric Patients
NCT ID: NCT00323310
Last Updated: 2010-10-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
92 participants
INTERVENTIONAL
2006-04-30
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Gadobenate Dimeglumine
gadobenate dimeglumine
A dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose.
Interventions
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gadobenate dimeglumine
A dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
2 Years
17 Years
ALL
No
Sponsors
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Bracco Diagnostics, Inc
INDUSTRY
Responsible Party
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Bracco Diagnostics, Inc
Principal Investigators
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Gianpaolo Pirovano, M.D.
Role: STUDY_DIRECTOR
Bracco Diagnostics, Inc
Locations
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Bracco Diagnostics, Inc.
Princeton, New Jersey, United States
Countries
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Other Identifiers
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MH 110
Identifier Type: -
Identifier Source: org_study_id