Clinical trial NCT00709852: Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging
Official title: A Multicenter, Randomized, Double-blind, Crossover, Phase 3 Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diagnostic Imaging
Central Nervous System Diseases
Keywords: Patients referred for a contrast-enhanced MRI of the CNS
CNS Imaging
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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

Detailed description: Issues on safety will be addressed in Adverse Events section.

Eligibility criteria: Inclusion Criteria:

* Is at least 18 years of age
* Is referred for a contrast-enhanced MRI of the CNS based on current clinical symptoms or results of a previous imaging procedure
* Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and has consented to participate

Exclusion Criteria:

* Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents
* Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
* Has severe cardiovascular disease (eg, known long QT syndrome, acute myocardial infarction \[\< 14 days\], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (\< 48 hours)- Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period

Primary outcomes:
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)
timeFrame: Up to 2 hours after injection of gadobutrol
Secondary outcomes:
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average Reader
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol
measure: Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadoteridol
measure: Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Comparison of Image Quality Between Gadobutrol and Gadoteridol by Blinded Readers
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Percentage of Participants for Which Blinded Readers Said Image Quality Was Higher
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Assessment of the Number of Contrast-enhanced Lesions for Gadobutrol and Gadoteridol by Blinded Readers
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
measure: Percentage of Lesion Enhancement From Unenhanced to Combined Unenhanced/Enhanced for Gadobutrol and Gadoteridol by Blinded Readers
timeFrame: Up to 2 hours after injection of gadobutrol or gadoteridol
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: West Alabama Research, Inc.
state: Alabama
city: Tuscaloosa
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Los Gatos
country: United States
facility: Los Gatos MRI
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Medical Group, Inc.
state: California
city: Jacksonville
country: United States
facility: University of Florida - Jacksonville
state: Florida
city: Evanston
country: United States
facility: NorthShore University HealthSystem-Evanston Hospital
state: Illinois
city: Atchison
country: United States
facility: Atchison Hospital
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Hospital System
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital/Health System
state: Maryland
city: Brockton
country: United States
facility: Shields MRI - Brockton
state: Massachusetts
city: West Roxbury
country: United States
facility: VA Boston Healthcare System-West Roxbury Division
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Alburquerque
country: United States
facility: University of New Mexico School of Medicine
state: New Mexico
city: Kingston
country: United States
facility: Kingston Neurological Associates, PC
state: New York
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Tulln
country: Austria
facility: Landeskrankenhaus Donauregion Tulln
state: Niederösterreich
city: Linz
country: Austria
facility: LNK Wagner Jauregg
state: Oberösterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Steiermark
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien Universitätskliniken
city: Medellín
country: Colombia
facility: Fundación Instituto de Alta tecnología médica de Antioquia
state: Antioquia
city: Bogotá
country: Colombia
facility: Fundación Santa Fe de Bogotá - Hospital Universitario
state: Cundinamarca
city: Cali
country: Colombia
facility: DIME Clinica Neurocardiovascular S.A.
state: Valle del Cauca
city: Medellín
country: Colombia
facility: Centro de Diagnostico Medico
city: Heidelberg
country: Germany
facility: Deutsches Krebsforschungszentrum
state: Baden-Württemberg
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe gGmbH
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Klinikum Mannheim gGmbH
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Zentralklinikum Augsburg
state: Bayern
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: München
country: Germany
facility: LMU Klinikum der Universität München - Großhadern
state: Bayern
city: München
country: Germany
facility: Klinikum rechts der Isar
state: Bayern
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann
state: Brandenburg
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
state: Hessen
city: Hannover
country: Germany
facility: Kliniken der Medizinischen Hochschule Hannover
state: Niedersachsen
city: Bonn
country: Germany
facility: Medizinische Einrichtungen der Universität Bonn
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: Medizinisches Versorgungszentrum Prof. Dr. D. Uhlenbrock
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Universitätsklinikum Köln
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Universitätskliniken des Saarlandes
state: Saarland
city: Dresden
country: Germany
facility: Medizinische Fakultät Carl Gustav Carus
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
state: Sachsen
city: Kiel
country: Germany
facility: Klinikum der Christian-Albrechts-Universität
state: Schleswig-Holstein
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt GmbH
state: Thüringen
city: Berlin
country: Germany
facility: Universitätsklinikum Charite zu Berlin
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf (UKE)
city: Indore
country: India
facility: CT /MRI centre
state: Madhya Pradesh
city: Mumbai
country: India
facility: Piramal Diagnostic- Jankharia Imaging
state: Maharashtra
city: Lucknow
country: India
facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences
city: Mumbai
country: India
facility: Bombay Hospital, Institute of Medical sciences
city: Nagoya
country: Japan
facility: Nagoya Kyoritsu Clinic
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya Kyoritsu Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Social Insurance Chukyo Hospital
state: Aichi
city: Himeji
country: Japan
facility: Himeji Medical Center
state: Hyogo
city: Himeji
country: Japan
facility: Himeji Central Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Institute of Biomedical Research and Innovation
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Shinsuma Hospital
state: Hyogo
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
state: Osaka
city: Shimonoseki
country: Japan
facility: Shimonoseki Kosei Hospital
state: Yamaguchi
city: Kyoto
country: Japan
facility: Utano National Hospital
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
city: Osaka
country: Japan
facility: Osaka National Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: Basel-Stadt
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
state: Sankt Gallen
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Genève
country: Switzerland
facility: Hôpital Cantonal Universitaire de Genève
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: