Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging

Completed · Phase 3

Conditions studied: Diagnostic Imaging, Central Nervous System Diseases

In brief

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.

Key facts

Study ID

NCT00709852

Run by

Bayer

People needed

402

Starts

2008-06-01

Expected to finish

2009-04-01

Last updated by the study team

2014-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Achieve Clinical Research, LLC — Tuscaloosa, Alabama, United States
• Los Gatos MRI — Los Gatos, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Redwood Regional Medical Group, Inc. — Santa Rosa, California, United States
• University of Florida - Jacksonville — Jacksonville, Florida, United States
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
• Atchison Hospital — Atchison, Kansas, United States
• University of Maryland Hospital System — Baltimore, Maryland, United States
• Johns Hopkins Hospital/Health System — Baltimore, Maryland, United States
• Shields MRI - Brockton — Brockton, Massachusetts, United States
• VA Boston Healthcare System-West Roxbury Division — West Roxbury, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of New Mexico School of Medicine — Albuquerque, New Mexico, United States
• Kingston Neurological Associates, PC — Kingston, New York, United States
• NYU Hospital for Joint Diseases — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Aurora Saint Luke's Medical Center — Milwaukee, Wisconsin, United States
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• West Alabama Research, Inc. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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