check_circleStudy Completed

Diagnostic imaging, Central Nervous System Diseases

Bayer Identifier:

91681

ClinicalTrials.gov Identifier:

NCT00709852

EudraCT Number:

2007-004746-33

EU CT Number:

Not Available
Safety and efficacy of gadobutrol 1.0 molar (Gadavist) in patients for central nervous system (CNS) imaging

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
402
Trial Dates
June 2008 - April 2009
Phase
Phase 3
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Leipzig, 04103, Germany
Completed
Augsburg, 865156, Germany
Completed
Erlangen, 91054, Germany
Withdrawn
München, 81377, Germany
Completed
Heidelberg, 69120, Germany
Completed
Frankfurt, 60488, Germany
Completed
Homburg, 66424, Germany
Completed
St. Louis, 63110, United States
Completed
Philadelphia, 19104, United States
Completed
Evanston, 60201, United States
Completed
Los Gatos, 95032, United States
Completed
Providence, 02903, United States
Completed
Karlsruhe, 76133, Germany
Completed
Berlin, 10117, Germany
Completed
Mannheim, 68167, Germany
Completed
Kiel, 24105, Germany
Completed
Dresden, 01307, Germany
Completed
Kiel, 24105, Germany
Withdrawn
Erfurt, 99089, Germany
Completed
Hannover, 30625, Germany
Completed
Köln, 50937, Germany
Completed
Potsdam, 14467, Germany
Withdrawn
München, 81675, Germany
Completed
Dortmund, 44263, Germany
Completed
Seattle, 98195, United States
Completed
Newport Beach, 92658-6100, United States
Completed
Tuscaloosa, 35406, United States
Completed
Charleston, 29425, United States
Completed
Jacksonville, 32209, United States
Completed
Osaka, 537-8511, Japan
Completed
Kyoto, 616-8255, Japan
Completed
Himeji, 672-8501, Japan
Completed
Shimonoseki, 750-0061, Japan
Completed
Osaka, 558-8558, Japan
Withdrawn
Kogarah, 2217, Australia
Completed
Westmead, 2145, Australia
Completed
Medellín, Colombia
Completed
Medellín, Colombia
Completed
Luzern, 6000, Switzerland
Completed
Genève, 1211, Switzerland
Completed
Birmingham, 35209, United States
Completed
Kingston, 12401, United States
Withdrawn
Pittsburgh, 15212, United States
Completed
Atchison, 66002, United States
Completed
Osaka, 540-0006, Japan
Completed
Kishiwada, 596-8522, Japan
Completed
Kobe, 654-0048, Japan
Completed
Himeji, 670-8520, Japan
Completed
Kobe, 650-0047, Japan
Completed
Nagoya, 457-8510, Japan
Completed
Nagoya, 454-0933, Japan
Withdrawn
Nagoya, 454-0933, Japan
Withdrawn
Camperdown, 2050, Australia
Completed
Clayton, 3168, Australia
Completed
Bern, 3010, Switzerland
Completed
Wien, 1090, Austria
Completed
Graz, 8036, Austria
Completed
Cali, Colombia
Withdrawn
St. Gallen, 9007, Switzerland
Completed
Basel, 4031, Switzerland
Withdrawn
Hamburg, 20246, Germany
Withdrawn
Bonn, 53105, Germany
Withdrawn
Kobe, 650-0047, Japan
Withdrawn
Linz, 4020, Austria
Withdrawn
Basel, 4031, Switzerland
Withdrawn
Bern, 3010, Switzerland

Primary Outcome

  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Blinded Readers
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI compared to Unenhanced MRI by Average Reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with more lesions detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with more lesions detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average Reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with more lesions detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI compared to Unenhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI compared to Unenhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Majority Reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI compared to Unenhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI compared to Unenhanced MRI by Majority Reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Percentage (per.) of the exact diagnostic matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI compared to Unenhanced MRI by Clinical Investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by majority reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by majority reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by majority reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Specificity of detection of malignant lesions (ML) for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by majority reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Specificity of detection of malignant lesions (ML) for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by majority reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by majority reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by majority reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Accuracy of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Sensitivity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Specificity of detection of malignant lesions (ML) for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by average reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Diagnostic confidence for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by average reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by average reader
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to unenhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol
    enhanced_encryption
    Safety Issue:
    No
  • Diagnostic confidence for combined unenhanced/gadoteridol-enhanced MRI compared to unenhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Diagnostic confidence for combined unenhanced/gadobutrol-enhanced MRI compared to combined unenhanced/gadoteridol-enhanced MRI by clinical investigator
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Comparison of image quality between gadobutrol and gadoteridol by blinded readers
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants for which blinded readers said image quality was higher
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of the number of contrast-enhanced lesions for gadobutrol and gadoteridol by blinded readers
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of lesion enhancement from unenhanced to combined unenhanced/enhanced for gadobutrol and gadoteridol by blinded readers
    date_rangeTime Frame:
    Up to 2 hours after injection of gadobutrol or gadoteridol
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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