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

Completed · Phase 3

Conditions studied: Central Nervous System Diseases

In brief

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.

Key facts

Study ID

NCT00623467

Run by

Bayer

People needed

343

Starts

2007-12-01

Expected to finish

2008-12-01

Last updated by the study team

2014-02-10

Who can join

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

You may qualify if…

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

You may not qualify if…

• Patients with acute renal insufficiency
• Patients with severe renal disease
• Patients with any contraindication to magnetic resonance imaging.

Where it is running

• HOPE Research Institute, LLC — Phoenix, Arizona, United States
• Scottsdale Medical Imaging, Ltd. — Scottsdale, Arizona, United States
• Radiology Ltd. — Tucson, Arizona, United States
• Landmark Imaging Medical Group — Los Angeles, California, United States
• Cedars- Sinai Medical Center — Los Angeles, California, United States
• Sharp & Children's MRI Center — San Diego, California, United States
• University of Florida - Jacksonville — Jacksonville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• River Birch Research Alliance, LLC — Blue Ridge, Georgia, United States
• Eisenhower Army Medical Center — Fort Gordon, Georgia, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Bio-Magnetic Resonance, Inc. — Madison Heights, Michigan, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• Hahnemann University Hospital — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baylor College of Medicine — Houston, Texas, United States
• Investigaciones Médicas — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Milbet Diagnostico por Imagenes — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Hospital Italiano Buenos Aires — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
• Centro de Diagnóstico Dr. Enrique Rossi — Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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