A Phase IV Double-blind Multicenter Randomized Crossover Study to Compare 0.10 mmol/kg of Multihance With 0.10 mmol.kg of Magnevist in Magnetic Resonance Imaging(MRI) of the Brain at 3T
18 Years
N/A
Both
Brain Tumor
Trial Information
A Phase IV Double-blind Multicenter Randomized Crossover Study to Compare 0.10 mmol/kg of Multihance With 0.10 mmol.kg of Magnevist in Magnetic Resonance Imaging(MRI) of the Brain at 3T
Inclusion Criteria:
- 18 years or older
- Provide 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:
- Pregnant or lactating females
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Outcome Measure:
Global Diagnostic Preference Between the Two Exams
Outcome Description:
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.
Outcome Time Frame:
Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Safety Issue:
No
Principal Investigator
Gianpaolo Priovano, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Bracco Diagnostics, Inc
Authority:
United States: Institutional Review Board
Study ID:
MH 126
NCT ID:
NCT00395863
Start Date:
November 2006
Completion Date:
March 2008
Related Keywords:
- Brain Tumor
- Brain Neoplasms
Name | Location |
|---|---|
| Bracco Diagnostics, Inc. | Princeton, New Jersey 08540 |
