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Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging

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ClinicalTrials.gov Identifier: NCT01660841
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
Purpose of the 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 images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).

Condition or disease Intervention/treatment Phase
Magnetic Resonance Imaging Drug: Gadobutrol (Gadovist, BAY86-4875) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Multicenter, Open-label, Phase III Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)
Study Start Date : September 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Gadobutrol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Gadobutrol (Gadovist, BAY86-4875)
A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.



Primary Outcome Measures :
  1. Scores for visualization parameter: degree of contrast enhancement [ Time Frame: Day of gadobutrol injection (Day 0) ]
    Blinded readers evaluate contrast of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.

  2. Scores for visualization parameter: border delineation [ Time Frame: Day of gadobutrol injection (Day 0) ]
    Blinded readers evaluate border delineation of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.

  3. Scores for visualization parameter: internal morphology [ Time Frame: Day of gadobutrol injection (Day 0) ]
    Blinded readers evaluate internal morphology of at maximum 5 lesions and 4 normal structures in scans taken with and without gadobutrol on a 3-point-scale.

  4. Number of detected lesions [ Time Frame: Day of gadobutrol injection (Day 0) ]
    Blinded readers determine number of detected lesions in scans with and without gadobutrol.


Secondary Outcome Measures :
  1. Percentage of exact match of the MRI diagnosis with the final clinical diagnosis [ Time Frame: Day of gadobutrol injection (Day 0) ]
    An exact match is defined as identical diagnosis given by the blinded reader and the independent standard of truth committee.

  2. Sensitivity and specificity to detect abnormal/normal brain tissue [ Time Frame: Day of gadobutrol injection (Day 0) ]
    Blinded readers classify the brain tissue as normal or abnormal based on the MRI sets.

  3. Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions [ Time Frame: Day of gadobutrol injection (Day 0) ]
    Percentage to correctly detect presence and absence of malignant lesions which are derived from the MR diagnosis of readers when compared with the diagnosis of the independent standard of truth committee.

  4. Number of participants with treatment emergent adverse events as a measure of safety and tolerability [ Time Frame: 3 days after injection (Day 3) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects referred for a contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system based on current clinical symptoms or results of a previous imaging procedure

Exclusion Criteria:

  • Subjects with any contraindication to the MRI examination
  • Subjects with severe renal disease to end stage renal disease
  • Subjects scheduled or are likely to require a biopsy or any interventional therapeutic procedure within 72 (±4) hours after the study MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660841


Locations
Japan
Nagoya, Aichi, Japan, 455-8530
Funabashi, Chiba, Japan, 274-8503
Kitakyushu, Fukuoka, Japan, 800-0057
Fukuyama, Hiroshima, Japan, 720-0825
Kobe, Hyogo, Japan, 650-0047
Kobe, Hyogo, Japan, 654-0047
Fujisawa, Kanagawa, Japan, 251-8550
Kawasaki, Kanagawa, Japan, 210-0013
Yokohama, Kanagawa, Japan, 226-0025
Daito, Osaka, Japan, 574-0074
Kishiwada, Osaka, Japan, 596-8522
Shimonoseki, Yamaguchi, Japan, 750-0061
Ube, Yamaguchi, Japan, 755-0151
Fukuoka, Japan, 810-0001
Fukuoka, Japan, 811-0213
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01660841     History of Changes
Other Study ID Numbers: 16260
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Keywords provided by Bayer:
Magnetic resonance imaging
central nervous system
contrast media
gadobutrol