Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
46 participants
INTERVENTIONAL
2006-11-30
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
TRIPLE
Study Groups
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MultiHance
0.5 M MultiHance at a single injection
Multihance
0.5 M at a single injection
Magnevist
0.5 M Magnevist at a single injection
Arm 2 - Magnevist
0.5 M Magnevist at a single dose injection
Interventions
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Multihance
0.5 M at a single injection
Arm 2 - Magnevist
0.5 M Magnevist at a single dose injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Provided written informed consent
* Scheduled for MRI
* Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI exams within 14 days
Exclusion Criteria
* Allergy to one or more of the ingredients in the products or hypersensitivity to any metals
* Congestive heart failure, class IV
* Previous stroke in the past year
* Received another contrast agent within 24 hours pre and post each exam
* Investigational product
* Contraindications to MRI
* Severe claustrophobia
* Surgery with 3 weeks prior
* Steroid therapy or radiosurgery between two exams
18 Years
ALL
No
Sponsors
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Bracco Diagnostics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Gianpaolo Priovano, 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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References
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Rumboldt Z, Rowley HA, Steinberg F, Maldjian JA, Ruscalleda J, Gustafsson L, Bastianello S. Multicenter, double-blind, randomized, intra-individual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine in MRI of brain tumors at 3 tesla. J Magn Reson Imaging. 2009 Apr;29(4):760-7. doi: 10.1002/jmri.21695.
Other Identifiers
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MH 126
Identifier Type: -
Identifier Source: org_study_id