<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01660841</url>
  </required_header>
  <id_info>
    <org_study_id>16260</org_study_id>
    <nct_id>NCT01660841</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging</brief_title>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the study is to look at the safety (what are the side effects) and efficacy (how&#xD;
      well does it work) of gadobutrol when used for taking images of the brain and spine. The&#xD;
      results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images&#xD;
      taken without contrast (gadobutrol).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scores for visualization parameter: degree of contrast enhancement</measure>
    <time_frame>Day of gadobutrol injection (Day 0)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scores for visualization parameter: border delineation</measure>
    <time_frame>Day of gadobutrol injection (Day 0)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scores for visualization parameter: internal morphology</measure>
    <time_frame>Day of gadobutrol injection (Day 0)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of detected lesions</measure>
    <time_frame>Day of gadobutrol injection (Day 0)</time_frame>
    <description>Blinded readers determine number of detected lesions in scans with and without gadobutrol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of exact match of the MRI diagnosis with the final clinical diagnosis</measure>
    <time_frame>Day of gadobutrol injection (Day 0)</time_frame>
    <description>An exact match is defined as identical diagnosis given by the blinded reader and the independent standard of truth committee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and specificity to detect abnormal/normal brain tissue</measure>
    <time_frame>Day of gadobutrol injection (Day 0)</time_frame>
    <description>Blinded readers classify the brain tissue as normal or abnormal based on the MRI sets.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions</measure>
    <time_frame>Day of gadobutrol injection (Day 0)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment emergent adverse events as a measure of safety and tolerability</measure>
    <time_frame>3 days after injection (Day 3)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">223</enrollment>
  <condition>Magnetic Resonance Imaging</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gadobutrol (Gadovist, BAY86-4875)</intervention_name>
    <description>A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects referred for a contrast-enhanced Magnetic Resonance Imaging (MRI) of the&#xD;
             central nervous system based on current clinical symptoms or results of a previous&#xD;
             imaging procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with any contraindication to the MRI examination&#xD;
&#xD;
          -  Subjects with severe renal disease to end stage renal disease&#xD;
&#xD;
          -  Subjects scheduled or are likely to require a biopsy or any interventional therapeutic&#xD;
             procedure within 72 (±4) hours after the study MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>455-8530</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Funabashi</city>
        <state>Chiba</state>
        <zip>274-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <zip>800-0057</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fukuyama</city>
        <state>Hiroshima</state>
        <zip>720-0825</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>654-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fujisawa</city>
        <state>Kanagawa</state>
        <zip>251-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>210-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>226-0025</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daito</city>
        <state>Osaka</state>
        <zip>574-0074</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kishiwada</city>
        <state>Osaka</state>
        <zip>596-8522</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shimonoseki</city>
        <state>Yamaguchi</state>
        <zip>750-0061</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ube</city>
        <state>Yamaguchi</state>
        <zip>755-0151</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fukuoka</city>
        <zip>810-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fukuoka</city>
        <zip>811-0213</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Magnetic resonance imaging</keyword>
  <keyword>central nervous system</keyword>
  <keyword>contrast media</keyword>
  <keyword>gadobutrol</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01660841
org study id: 16260
nct id: NCT01660841
lead sponsor: 
has dmc: No
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).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Scores for visualization parameter: degree of contrast enhancement
time frame: Day of gadobutrol injection (Day 0)
description: 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.
measure: Scores for visualization parameter: border delineation
time frame: Day of gadobutrol injection (Day 0)
description: 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.
measure: Scores for visualization parameter: internal morphology
time frame: Day of gadobutrol injection (Day 0)
description: 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.
measure: Number of detected lesions
time frame: Day of gadobutrol injection (Day 0)
description: Blinded readers determine number of detected lesions in scans with and without gadobutrol.
measure: Percentage of exact match of the MRI diagnosis with the final clinical diagnosis
time frame: Day of gadobutrol injection (Day 0)
description: An exact match is defined as identical diagnosis given by the blinded reader and the independent standard of truth committee.
measure: Sensitivity and specificity to detect abnormal/normal brain tissue
time frame: Day of gadobutrol injection (Day 0)
description: Blinded readers classify the brain tissue as normal or abnormal based on the MRI sets.
measure: Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions
time frame: Day of gadobutrol injection (Day 0)
description: 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.
measure: Number of participants with treatment emergent adverse events as a measure of safety and tolerability
time frame: 3 days after injection (Day 3)
arm group label: Arm 1
arm group type: Experimental
intervention type: Drug
intervention name: Gadobutrol (Gadovist, BAY86-4875)
description: A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.
arm group label: Arm 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
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country: Japan
responsible party type: Sponsor