Phase IV, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.10 Mmol/kg of MultiHance With 0.10 Omniscan in Magnetic Resonance Imaging (MRI) of the Brain
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Brain Pathology
Both
Brain Pathology
Trial Information
Phase IV, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.10 Mmol/kg of MultiHance With 0.10 Omniscan in Magnetic Resonance Imaging (MRI) of the Brain
Inclusion Criteria:
- 18 yrs of age or older; provide written informed consent; scheduled to undergo MRI;
willing to undergo 2 MRI exams within 14 days
Exclusion Criteria:
- Known allergy to one or more ingredients in the test agents; severe CHF (Class IV);
suffered stroke one year ago; pregnancy or lactating females; contraindications to
MRI; severe claustrophobia; scheduled to receive surgery prior to or between the two
MRI exams, or steroids or radiosurgery between the two MRI exams
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind
Outcome Measure:
Superiority of Multihance in terms of by-patient global diagnostic performance
Outcome Time Frame:
immediately post dose
Safety Issue:
No
Principal Investigator
Barry Hogstrom, M. D.
Investigator Role:
Study Director
Investigator Affiliation:
Bracco Diagnostics, Inc
Authority:
United States: Food and Drug Administration
Study ID:
MH 130
NCT ID:
NCT00323102
Start Date:
May 2006
Completion Date:
March 2007
Related Keywords:
- Brain Pathology
- Brain Diseases
Name | Location |
|---|---|
| Bracco Diagnostics, Inc. | Princeton, New Jersey 08540 |
