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

Last updated: January 16, 2014
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00623467
91682
  • Ages > 18
  • All Genders

Study Summary

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients referred for contrast enhanced MRI of the CNS based on symptoms or previousprocedures.

Exclusion

Exclusion Criteria:

  • Patients with acute renal insufficiency

  • Patients with severe renal disease

  • Patients with any contraindication to magnetic resonance imaging.

Study Design

Total Participants: 343
Study Start date:
December 01, 2007
Estimated Completion Date:
December 31, 2008

Study Description

Issues on safety will be addressed in Adverse Events section.

Connect with a study center

  • Centro de Diagnóstico Dr. Enrique Rossi

    Buenos Aires, Ciudad Auton. de Buenos Aires C1425BEE
    Argentina

    Site Not Available

  • Hospital Italiano Buenos Aires

    Buenos Aires, Ciudad Auton. de Buenos Aires C1181ACH
    Argentina

    Site Not Available

  • Investigaciones Médicas

    Buenos Aires, Ciudad Auton. de Buenos Aires C1082A
    Argentina

    Site Not Available

  • Milbet Diagnostico por Imagenes

    Buenos Aires, Ciudad Auton. de Buenos Aires C1115AAB
    Argentina

    Site Not Available

  • Zhongda Hosp. affiliated of Southeast Univ.

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • The 1st Affiliated Hosp of the 4th Military Med Uni

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Chinese PLA General Hosp.

    Beijing, 100853
    China

    Site Not Available

  • Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School

    Shanghai, 200025
    China

    Site Not Available

  • Fudan University Huashan Hospital

    Shanghai, 200040
    China

    Site Not Available

  • Instituto de Alta Tecnologia Medica de Antioquia

    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

  • Fundación Santa Fe de Bogotá - Hospital Universitario

    Bogotá, Cundinamarca
    Colombia

    Site Not Available

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, Korea 110-744
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 138-736
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 110-799
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University College of Medicine

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

  • HOPE Research Institute, LLC

    Phoenix, Arizona 85050
    United States

    Site Not Available

  • Scottsdale Medical Imaging, Ltd.

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Radiology Ltd.

    Tucson, Arizona 85711
    United States

    Site Not Available

  • Cedars- Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Landmark Imaging Medical Group

    Los Angeles, California 90025
    United States

    Site Not Available

  • Sharp & Children's MRI Center

    San Diego, California 92123
    United States

    Site Not Available

  • University of Florida - Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • River Birch Research Alliance, LLC

    Blue Ridge, Georgia 30513
    United States

    Site Not Available

  • Eisenhower Army Medical Center

    Fort Gordon, Georgia 30905
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48109-5302
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Bio-Magnetic Resonance, Inc.

    Madison Heights, Michigan 48071
    United States

    Site Not Available

  • Maimonides Medical Center

    Brooklyn, New York 11219
    United States

    Site Not Available

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania 19102
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

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