Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

PHASE2CompletedINTERVENTIONAL
Enrollment

237

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

March 31, 2007

Study Completion Date

March 31, 2007

Conditions
Brain DiseasesSpinal Cord Diseases
Interventions
DRUG

Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

DRUG

Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

DRUG

Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

DRUG

OptiMARK~0.1 mmol/kg BW

Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Trial Locations (27)

10016

NYU Langone Medical Center, New York

15213

University of Pittsburgh Medical Center Health System, Pittsburgh

19104

Hospital of the University of Pennsylvania, Philadelphia

19146

Temple University Hospital, Philadelphia

21287

Johns Hopkins University School of Medicine, Baltimore

27599

University of North Carolina, Chapel Hill

29425

Medical University of South Carolina, Charleston

30322

Emory University School of Medicine, Atlanta

32209

Shands Jacksonville Medical Center, Jacksonville

38104

Methodist Le Bonheur Healthcare, Memphis

46260

Indiana Neuroscience Institute, Indianapolis

53792

University of Wisconsin - Madison, Madison

60611

Northwestern Memorial Hospital, Chicago

63110

Washington University School of Medicine, St Louis

68114

Methodist Hospital, Omaha

92103

University of California-San Diego Medical Center, San Diego

95817

University of California Davis Medical Center, Sacramento

98195

University of Washington Medical Center, Seattle

02118

Boston Medical Center, Boston

02903

Rhode Island Hospital, Providence

Unknown

TCba Salguero, Buenos Aires

Centro de Diagnostico Medico, Medellín

Fundación Instituto de Alta tecnología médica de Antioquia, Medellín

DIME Clinica Neurocardiovascular S.A., Santiago de Cali

Fundación Clínica Valle del Lili, Santiago de Cali

B1832BQS

Fundacion Cientifica del Sur, Lornas de Zamora

01323-001

Hospital da Beneficiência Portuguesa, São Paulo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY