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

Last updated: December 8, 2014
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00709852
91681
2007-004746-33
310123
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is at least 18 years of age

  • Is referred for a contrast-enhanced MRI of the CNS based on current clinical symptomsor results of a previous imaging procedure

  • Has been fully informed about the study, including provisions of the Health InsurancePortability and Accountability Act (HIPAA) as applicable, and has consented toparticipate

Exclusion

Exclusion Criteria:

  • Has any contraindication to the MRI examinations or the use of Gd-containing contrastagents

  • Has a history of severe allergic or anaphylactoid reaction to any allergen includingdrugs and contrast agents

  • Has severe cardiovascular disease (eg, known long QT syndrome, acute myocardialinfarction [< 14 days], unstable angina, congestive heart failure New York HeartAssociation class IV) or acute stroke (< 48 hours)- Patients with acute renalinsufficiency of any severity due to hepato-renal syndrome or in the perioperativeliver transplantation period

Study Design

Total Participants: 402
Study Start date:
June 01, 2008
Estimated Completion Date:
April 30, 2009

Study Description

Issues on safety will be addressed in Adverse Events section.

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • St George Hospital

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • empty

    Sydney, New South Wales 2145
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • empty

    Melbourne, Victoria 3168
    Australia

    Site Not Available

  • Landeskrankenhaus Donauregion Tulln

    Tulln, Niederösterreich 3430
    Austria

    Site Not Available

  • LNK Wagner Jauregg

    Linz, Oberösterreich 4020
    Austria

    Site Not Available

  • Medizinische Universität Graz

    Graz, Steiermark 8036
    Austria

    Site Not Available

  • Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

    Wien, 1090
    Austria

    Site Not Available

  • empty

    Medellín, Antioquia
    Colombia

    Site Not Available

  • Fundación Instituto de Alta tecnología médica de Antioquia

    Medellín, Antioquia
    Colombia

    Site Not Available

  • Fundación Santa Fe de Bogotá - Hospital Universitario

    Bogotá, Cundinamarca
    Colombia

    Site Not Available

  • DIME Clinica Neurocardiovascular S.A.

    Cali, Valle del Cauca
    Colombia

    Site Not Available

  • empty

    Bogotá,
    Colombia

    Site Not Available

  • Centro de Diagnostico Medico

    Medellín,
    Colombia

    Site Not Available

  • Deutsches Krebsforschungszentrum

    Heidelberg, Baden-Württemberg 69120
    Germany

    Site Not Available

  • Städtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, Baden-Württemberg 76133
    Germany

    Site Not Available

  • Klinikum Mannheim gGmbH

    Mannheim, Baden-Württemberg 68167
    Germany

    Site Not Available

  • Zentralklinikum Augsburg

    Augsburg, Bayern 865156
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • empty

    München, Bayern 81377
    Germany

    Site Not Available

  • Klinikum rechts der Isar

    München, Bayern 81675
    Germany

    Site Not Available

  • LMU Klinikum der Universität München - Großhadern

    München, Bayern 81377
    Germany

    Site Not Available

  • Klinikum Ernst von Bergmann

    Potsdam, Brandenburg 14467
    Germany

    Site Not Available

  • Krankenhaus Nordwest

    Frankfurt, Hessen 60488
    Germany

    Site Not Available

  • Kliniken der Medizinischen Hochschule Hannover

    Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • Medizinische Einrichtungen der Universität Bonn

    Bonn, Nordrhein-Westfalen 53105
    Germany

    Site Not Available

  • Medizinisches Versorgungszentrum Prof. Dr. D. Uhlenbrock

    Dortmund, Nordrhein-Westfalen 44263
    Germany

    Site Not Available

  • empty

    Köln, Nordrhein-Westfalen 50931
    Germany

    Site Not Available

  • Universitätsklinikum Köln

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Universitätskliniken des Saarlandes

    Homburg, Saarland 66424
    Germany

    Site Not Available

  • Medizinische Fakultät Carl Gustav Carus

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig AöR

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Klinikum der Christian-Albrechts-Universität

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • HELIOS Klinikum Erfurt GmbH

    Erfurt, Thüringen 99089
    Germany

    Site Not Available

  • Universitätsklinikum Charite zu Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg Eppendorf (UKE)

    Hamburg, 20246
    Germany

    Site Not Available

  • CT /MRI centre

    Indore, Madhya Pradesh 252002
    India

    Site Not Available

  • Piramal Diagnostic- Jankharia Imaging

    Mumbai, Maharashtra 400004
    India

    Site Not Available

  • Sanjay Gandhi Post Graduate Institute of Medical Sciences

    Lucknow, 226 014
    India

    Site Not Available

  • Bombay Hospital, Institute of Medical sciences

    Mumbai, 400020
    India

    Site Not Available

  • empty

    Nagaya, Aichi 457-8510
    Japan

    Site Not Available

  • Nagoya Kyoritsu Clinic

    Nagoya, Aichi 454-0933
    Japan

    Site Not Available

  • Nagoya Kyoritsu Hospital

    Nagoya, Aichi 454-0933
    Japan

    Site Not Available

  • Social Insurance Chukyo Hospital

    Nagoya, Aichi 457-8510
    Japan

    Site Not Available

  • Himeji Central Hospital

    Himeji, Hyogo 672-8501
    Japan

    Site Not Available

  • Himeji Medical Center

    Himeji, Hyogo 670-8520
    Japan

    Site Not Available

  • Institute of Biomedical Research and Innovation

    Kobe, Hyogo 650-0047
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Kobe, Hyogo 650-0047
    Japan

    Site Not Available

  • Shinsuma Hospital

    Kobe, Hyogo 654-0047
    Japan

    Site Not Available

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka 596-8522
    Japan

    Site Not Available

  • Shimonoseki Kosei Hospital

    Shimonoseki, Yamaguchi 750-0061
    Japan

    Site Not Available

  • Utano National Hospital

    Kyoto, 616-8255
    Japan

    Site Not Available

  • Osaka General Medical Center

    Osaka, 558-8558
    Japan

    Site Not Available

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka, 537-8511
    Japan

    Site Not Available

  • Osaka National Hospital

    Osaka, 540-0006
    Japan

    Site Not Available

  • Universitätsspital Basel

    Basel, Basel-Stadt 4031
    Switzerland

    Site Not Available

  • Kantonsspital St. Gallen

    St. Gallen, Sankt Gallen 9007
    Switzerland

    Site Not Available

  • Inselspital Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • empty

    Genève, 1211
    Switzerland

    Site Not Available

  • Hôpital Cantonal Universitaire de Genève

    Genève, 1211
    Switzerland

    Site Not Available

  • Luzerner Kantonsspital

    Luzern, 6000
    Switzerland

    Site Not Available

  • West Alabama Research, Inc.

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Achieve Clinical Research, LLC

    Tuscaloosa, Alabama 35406
    United States

    Site Not Available

  • Los Gatos MRI

    Los Gatos, California 95032
    United States

    Site Not Available

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California 92658-6100
    United States

    Site Not Available

  • Redwood Regional Medical Group, Inc.

    Santa Rosa, California 95403
    United States

    Site Not Available

  • University of Florida - Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Atchison Hospital

    Atchison, Kansas 66002
    United States

    Site Not Available

  • Johns Hopkins Hospital/Health System

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • University of Maryland Hospital System

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Shields MRI - Brockton

    Brockton, Massachusetts 02301
    United States

    Site Not Available

  • VA Boston Healthcare System-West Roxbury Division

    West Roxbury, Massachusetts 02132
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • University of New Mexico School of Medicine

    Alburquerque, New Mexico 87131
    United States

    Site Not Available

  • Kingston Neurological Associates, PC

    Kingston, New York 12401
    United States

    Site Not Available

  • NYU Hospital for Joint Diseases

    New York, New York 10003
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27707
    United States

    Site Not Available

  • The Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.