Status:
COMPLETED
Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging
Lead Sponsor:
Bayer
Conditions:
Diagnostic Imaging
Central Nervous System Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what ...
Detailed Description
Issues on safety will be addressed in Adverse Events section.
Eligibility Criteria
Inclusion
- Is at least 18 years of age
- Is referred for a contrast-enhanced MRI of the CNS based on current clinical symptoms or results of a previous imaging procedure
- Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and has consented to participate
Exclusion
- Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents
- Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
- Has severe cardiovascular disease (eg, known long QT syndrome, acute myocardial infarction \[\< 14 days\], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (\< 48 hours)- Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00709852
Start Date
June 1 2008
End Date
April 1 2009
Last Update
December 30 2014
Active Locations (79)
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1
West Alabama Research, Inc.
Birmingham, Alabama, United States, 35209
2
Achieve Clinical Research, LLC
Tuscaloosa, Alabama, United States, 35406
3
Los Gatos MRI
Los Gatos, California, United States, 95032
4
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658-6100