Trial Condition(s):

Central nervous system diseases

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

Bayer Identifier:

91682

ClinicalTrials.gov Identifier:

NCT00623467

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Patients referred for contrast enhanced MRI of the CNS based on symptoms or previous procedures.
Exclusion Criteria
- Patients with acute renal insufficiency
 - Patients with severe renal disease
 - Patients with any contraindication to magnetic resonance imaging.

Trial Summary

Enrollment Goal
343
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

Cedars- Sinai Medical Center

Los Angeles, United States, 90048

Status
Terminated
 
Locations

Mount Sinai Medical Center

New York, United States, 10029

Status
Terminated
 
Locations

Henry Ford Health System

Detroit, United States, 48202

Status
Completed
 
Locations

University of Rochester Medical Center

Rochester, United States, 14642

Status
Terminated
 
Locations

Sharp & Children's MRI Center

San Diego, United States, 92123

Status
Terminated
 
Locations

Landmark Imaging Medical Group

Los Angeles, United States, 90025

Status
Terminated
 
Locations

University of South Florida

Tampa, United States, 33606

Status
Terminated
 
Locations

Bio-Magnetic Resonance, Inc.

Madison Heights, United States, 48071

Status
Terminated
 
Locations

Hahnemann University Hospital

Philadelphia, United States, 19102

Status
Completed
 
Locations

Eisenhower Army Medical Center

Fort Gordon, United States, 30905

Status
Completed
 
Locations

Medical University of South Carolina

Charleston, United States, 29425

Status
Terminated
 
Locations

Allegheny General Hospital

Pittsburgh, United States, 15212

Status
Completed
 
Locations

HOPE Research Institute, LLC

Phoenix, United States, 85050

Status
Terminated
 
Locations

Investigaciones Médicas

Buenos Aires, Argentina, C1082A

Status
Completed
 
Locations

University of Florida - Jacksonville

Jacksonville, United States, 32209

Status
Completed
 
Locations

Baylor College of Medicine

Houston, United States, 77030

Status
Terminated
 
Locations

Radiology Ltd.

Tucson, United States, 85711

Status
Completed
 
Locations

Wake Forest University School of Medicine

Winston-Salem, United States, 27157

Status
Terminated
 
Locations

Scottsdale Medical Imaging, Ltd.

Scottsdale, United States, 85258

Status
Completed
 
Locations

University of Michigan Health System

Ann Arbor, United States, 48109-5302

Status
Terminated
 
Locations

River Birch Research Alliance, LLC

Blue Ridge, United States, 30513

Status
Terminated
 
Locations

Maimonides Medical Center

Brooklyn, United States, 11219

Status
Terminated
 
Locations

Eisenhower Army Medical Center

Fort Gordon, United States, 30905

Status
Terminated
 
Locations

Hospital Italiano Buenos Aires

Buenos Aires, Argentina, C1181ACH

Status
Completed
 
Locations

Centro de Diagnóstico Dr. Enrique Rossi

Buenos Aires, Argentina, C1425BEE

Status
Completed
 
Locations

Fundación Santa Fe de Bogotá - Hospital Universitario

Bogotá, Colombia

Status
Completed
 
Locations

Chinese PLA General Hosp.

Beijing, China, 100853

Status
Completed
 
Locations

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

Xi'an, China, 710032

Status
Completed
 
Locations

Milbet Diagnostico por Imagenes

Buenos Aires, Argentina, C1115AAB

Status
Completed
 
Locations

Fundación Instituto de Alta tecnología médica de Antioquia

Medellín, Colombia

Status
Completed
 
Locations

Fudan University Huashan Hospital

Shanghai, China, 200040

Status
Terminated
 
Locations

Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School

Shanghai, China, 200025

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-799

Status
Completed
 
Locations

Samsung Medical Center

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea, 120-752

Status
Completed
 
Locations

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

Seoul, South Korea, 110-744

Status
Completed
 
Locations

Zhongda Hosp. affiliated of Southeast Univ.

Nanjing, China, 210009

Status
Completed
 

Trial Design