Trial Condition(s):

Diagnostic Imaging, Central nervous system diseases

Safety and efficacy of gadobutrol 1.0 molar (Gadavist) in patients for central nervous system (CNS) imaging

Bayer Identifier:

91681

ClinicalTrials.gov Identifier:

NCT00709852

EudraCT Number:

2007-004746-33

Study Completed

Trial Purpose

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 are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.

Inclusion Criteria
- 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 Criteria
- 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

Trial Summary

Enrollment Goal
402
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Augsburg, Germany, 865156

Status
Completed
 
Locations

Investigative Site

Erlangen, Germany, 91054

Status
Completed
 
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Investigative Site

Heidelberg, Germany, 69120

Status
Completed
 
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Investigative Site

Frankfurt, Germany, 60488

Status
Completed
 
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Investigative Site

Homburg, Germany, 66424

Status
Completed
 
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Investigative Site

St. Louis, United States, 63110

Status
Completed
 
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Investigative Site

Philadelphia, United States, 19104

Status
Completed
 
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Investigative Site

Evanston, United States, 60201

Status
Completed
 
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Investigative Site

Los Gatos, United States, 95032

Status
Completed
 
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Investigative Site

Providence, United States, 02903

Status
Completed
 
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Investigative Site

Karlsruhe, Germany, 76133

Status
Completed
 
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Investigative Site

Berlin, Germany, 10117

Status
Completed
 
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Investigative Site

Mannheim, Germany, 68167

Status
Completed
 
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Investigative Site

Kiel, Germany, 24105

Status
Completed
 
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Investigative Site

Dresden, Germany, 01307

Status
Completed
 
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Investigative Site

Hannover, Germany, 30625

Status
Completed
 
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Investigative Site

Köln, Germany, 50937

Status
Completed
 
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Investigative Site

Potsdam, Germany, 14467

Status
Completed
 
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Investigative Site

Dortmund, Germany, 44263

Status
Completed
 
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Investigative Site

Seattle, United States, 98195

Status
Completed
 
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Investigative Site

Newport Beach, United States, 92658-6100

Status
Completed
 
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Investigative Site

Tuscaloosa, United States, 35406

Status
Completed
 
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Investigative Site

Charleston, United States, 29425

Status
Completed
 
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Investigative Site

Jacksonville, United States, 32209

Status
Completed
 
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Investigative Site

Osaka, Japan, 537-8511

Status
Completed
 
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Investigative Site

Kyoto, Japan, 616-8255

Status
Completed
 
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Investigative Site

Himeji, Japan, 672-8501

Status
Completed
 
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Investigative Site

Shimonoseki, Japan, 750-0061

Status
Completed
 
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Investigative Site

Osaka, Japan, 558-8558

Status
Completed
 
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Investigative Site

Westmead, Australia, 2145

Status
Completed
 
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Investigative Site

Medellín, Colombia

Status
Completed
 
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Investigative Site

Medellín, Colombia

Status
Completed
 
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Investigative Site

Luzern, Switzerland, 6000

Status
Completed
 
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Investigative Site

Genève, Switzerland, 1211

Status
Completed
 
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Investigative Site

Birmingham, United States, 35209

Status
Completed
 
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Investigative Site

Kingston, United States, 12401

Status
Completed
 
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Investigative Site

Atchison, United States, 66002

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 540-0006

Status
Completed
 
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Investigative Site

Kishiwada, Japan, 596-8522

Status
Completed
 
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Investigative Site

Kobe, Japan, 654-0048

Status
Completed
 
Locations

Investigative Site

Himeji, Japan, 670-8520

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 650-0047

Status
Completed
 
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Investigative Site

Nagoya, Japan, 457-8510

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 454-0933

Status
Completed
 
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Investigative Site

Clayton, Australia, 3168

Status
Completed
 
Locations

Investigative Site

Bern, Switzerland, 3010

Status
Completed
 
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Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
 
Locations

Investigative Site

Cali, Colombia

Status
Completed
 
Locations

Investigative Site

Basel, Switzerland, 4031

Status
Completed
 

Trial Design