Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging
NCT ID: NCT00623467
Last Updated: 2014-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
343 participants
INTERVENTIONAL
2007-12-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Gadobutrol (Gadavist, BAY86-4875)
Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.
Interventions
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Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with severe renal disease
* Patients with any contraindication to magnetic resonance imaging.
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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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
Zhongda Hosp. affiliated of Southeast Univ.
Nanjing, Jiangsu, China
The 1st Affiliated Hosp of the 4th Military Med Uni
Xi'an, Shaanxi, China
Chinese PLA General Hosp.
Beijing, , China
Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School
Shanghai, , China
Fudan University Huashan Hospital
Shanghai, , China
Fundación Instituto de Alta tecnología médica de Antioquia
Medellín, Antioquia, Colombia
Fundación Santa Fe de Bogotá - Hospital Universitario
Bogotá, Cundinamarca, Colombia
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Korea, South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University College of Medicine
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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91682
Identifier Type: -
Identifier Source: org_study_id
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