<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/NCT02186054</url>
  </required_header>
  <id_info>
    <org_study_id>T2 Weighted MRI Liver</org_study_id>
    <nct_id>NCT02186054</nct_id>
  </id_info>
  <brief_title>T2 Weighted Imaging of the Liver With Fast Spin Echo MRI</brief_title>
  <official_title>Enhancement of T2 Weighted Imaging of the Liver With Fast Spin Echo Magnetic Resonance Imaging (MRI).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test two new MRI (magnetic resonance imaging) sequences to&#xD;
      see how they compare to previously used imaging sequences as they may improve the quality of&#xD;
      abdominal MRI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Approximately 50 patients undergoing routine liver MRI in our practice imaged with one&#xD;
           of our 4 clinical scanners will undergo our standard liver MRI protocol with the&#xD;
           addition of 2 breath-hold sequences (FSE Flex and eSSFSE) only increasing the scan time&#xD;
           by approximately 3 minutes.&#xD;
&#xD;
        -  Data will be retrieved from examinations that have been performed from the patient's&#xD;
           electronic imaging file stored in our picture archiving and communication system (PACS).&#xD;
&#xD;
        -  Images will be completely anonymized. No patient identifiers will be available on the&#xD;
           images during the analysis.&#xD;
&#xD;
        -  Analyses will include the visual assessment of image quality, presence and severity of&#xD;
           imaging artifact and other non-invasive imaging outcomes performed by radiologists&#xD;
           blinded to patient information and the type of sequence performed. Data will be&#xD;
           presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and&#xD;
           5=excellent) and imaging parameters will be compared using the Wilcoxon sign rank test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Trial Logistics&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <phase>N/A</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of abdominal MRI scans deemed improved quality</measure>
    <time_frame>Regular scan time with one of 4 clinical scanners plus 3 additional minutes</time_frame>
    <description>Data is presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters are compared using the Wilcoxon sign rank test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of MRI scans that display severity of imaging artifact</measure>
    <time_frame>Regular scan time with one of 4 clinical scanners plus 3 additional minutes</time_frame>
    <description>Data is presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters are compared using the Wilcoxon sign rank test.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Liver Disease</condition>
  <arm_group>
    <arm_group_label>Imaging- MRI examinations</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Liver MRI imaging will be performed on 50 patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI examinations</intervention_name>
    <description>Consented patients will be required to stay in the MRI scanner to complete the 2 additional sequences once their standard exam is completed.</description>
    <arm_group_label>Imaging- MRI examinations</arm_group_label>
    <other_name>MRI</other_name>
    <other_name>FSE Flex</other_name>
    <other_name>Enhanced single shot FSE (eSSFSE)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing routine liver MRI imaged with one of our 4 clinical scanners (MR&#xD;
             750W, General Electric, Milwaukee WI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not undergoing routine liver MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nick Schieda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OHRI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ottawa Hospital (Civic Campus)</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>November 17, 2015</last_update_submitted>
  <last_update_submitted_qc>November 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Abdominal-Pelvic MRI (magnetic resonance image)</keyword>
  <keyword>T2W (T2 weighted)</keyword>
  <keyword>FSE Flex (recently developed MRI pulse sequence)</keyword>
  <keyword>Enhanced single shot FSE (fast spin echo).</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <!-- 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/NCT02186054
org study id: T2 Weighted MRI Liver
nct id: NCT02186054
lead sponsor: 
has dmc: No
The purpose of this study is to test two new MRI (magnetic resonance imaging) sequences to
      see how they compare to previously used imaging sequences as they may improve the quality of
      abdominal MRI.
-  Approximately 50 patients undergoing routine liver MRI in our practice imaged with one
           of our 4 clinical scanners will undergo our standard liver MRI protocol with the
           addition of 2 breath-hold sequences (FSE Flex and eSSFSE) only increasing the scan time
           by approximately 3 minutes.

        -  Data will be retrieved from examinations that have been performed from the patient's
           electronic imaging file stored in our picture archiving and communication system (PACS).

        -  Images will be completely anonymized. No patient identifiers will be available on the
           images during the analysis.

        -  Analyses will include the visual assessment of image quality, presence and severity of
           imaging artifact and other non-invasive imaging outcomes performed by radiologists
           blinded to patient information and the type of sequence performed. Data will be
           presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and
           5=excellent) and imaging parameters will be compared using the Wilcoxon sign rank test.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: The number of abdominal MRI scans deemed improved quality
time frame: Regular scan time with one of 4 clinical scanners plus 3 additional minutes
description: Data is presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters are compared using the Wilcoxon sign rank test.
measure: The number of MRI scans that display severity of imaging artifact
time frame: Regular scan time with one of 4 clinical scanners plus 3 additional minutes
description: Data is presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters are compared using the Wilcoxon sign rank test.
arm group label: Imaging- MRI examinations
arm group type: Other
description: Liver MRI imaging will be performed on 50 patients.
intervention type: Device
intervention name: MRI examinations
description: Consented patients will be required to stay in the MRI scanner to complete the 2 additional sequences once their standard exam is completed.
arm group label: Imaging- MRI examinations
other name: MRI
other name: FSE Flex
other name: Enhanced single shot FSE (eSSFSE)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nick Schieda, MD
role: Principal Investigator
affiliation: OHRI
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Body Weight