<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/NCT03030872</url>
  </required_header>
  <id_info>
    <org_study_id>AD0542</org_study_id>
    <nct_id>NCT03030872</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of CARESTREAM Vue PACS v12.2 MR Perfusion and Diffusion</brief_title>
  <official_title>Clinical Evaluation of CARESTREAM Vue PACS v12.2 MR Perfusion and Diffusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carestream Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carestream Health, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare the diagnostic value of MR DSC-Perfusion (Perfusion&#xD;
      Module), MR DWI (Diffusion Module) and MR DTI (Diffusion Module) in CARESTREAM Vue PACS&#xD;
      (&quot;investigational device&quot;) to the Olea Sphere PACS with Perfusion and DWI Modules (&quot;predicate&#xD;
      device&quot;). Therefore, there will be several separate objectives depending on the type of&#xD;
      acquisition:&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Carestream Health, Inc. will investigate the imaging performance of the CARESTREAM Vue PACS&#xD;
      v12.2 Magnetic Resonance (MR) Perfusion and Diffusion Weighted Imaging (&quot;investigational&#xD;
      device&quot;) performance. Evaluation of MR Dynamic Susceptibility Contrast-Enhanced Perfusion&#xD;
      Weighted Imaging (DSC-Perfusion), MR Diffusion Weighted Imaging (DWI) and MR Diffusion Tensor&#xD;
      Imaging (DTI) was compared to the predicate device, the Olea Sphere PACS with Perfusion and&#xD;
      DWI Modules. MR DSC-Perfusion of the brain is a method for evaluating blood flow in the brain&#xD;
      and producing optimized parametric maps that help visualize this blood flow. MR DWI is a&#xD;
      method to evaluate the motion of water molecules within bodily tissues. MR DTI is an&#xD;
      extension of DWI that allows extraction of the diffusion tensor. The purpose of this study is&#xD;
      to demonstrate equivalent clinical quality between the investigational and predicate devices&#xD;
      using a radiologist evaluation of key metrics which are applicable to MR DSC-Perfusion, MR&#xD;
      DWI, and MR DTI images.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2017</start_date>
  <completion_date type="Actual">January 12, 2017</completion_date>
  <primary_completion_date type="Actual">January 12, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic value comparison of Carestream Vue PACS v12.2 MR Perfusion and Diffusion (investigational software) images to the Olea Shere PACS with Perfusion and DWI Modules (predicate software) images.</measure>
    <time_frame>January 2017</time_frame>
    <description>Diagnostic value of investigational images compared to the diagnostic value of predicate images as assessed by a radiologist evaluation of key metrics.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">68</enrollment>
  <condition>Ischemia</condition>
  <arm_group>
    <arm_group_label>Predicate software</arm_group_label>
    <description>Olea Sphere PACS with Perfusion and DWI Modules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Investigational software</arm_group_label>
    <description>Vue PACS v12.2 Magnetic Resonance (MR) Perfusion and Diffusion Weighted Imaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Investigational software</intervention_name>
    <description>The study evaluated retrospective de-identified cases that were processed after the imaging procedure had been completed (off-line) using a dedicated workstation.</description>
    <arm_group_label>Investigational software</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of retrospective de-identified adult patient MR&#xD;
        DSC-Perfusion, DWI, and DTI (if available) cases collected under Ethics Committee/IRB&#xD;
        approval. The Ethics Committee/IRB submission will request a waiver of patient informed&#xD;
        consent in compliance with local country regulations, and must meet the study inclusion and&#xD;
        exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Retrospective patient MR DSC-Perfusion cases with subject/patient 18 years of age or&#xD;
             older.&#xD;
&#xD;
          -  Retrospective patient MR DWI with subject/patient 18 years of age or older.&#xD;
&#xD;
          -  Retrospective patient MR DTI cases with subject/patient 18 years of age or older.&#xD;
&#xD;
          -  Informed consent is not required if waiver of consent is approved by the hospital&#xD;
             IRB/Ethics Committee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Low quality images, or images that are not clinically acceptable for clinical&#xD;
             diagnostic reading as determined by the Principal Investigator&#xD;
&#xD;
          -  Subject less than 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Susan Pate, MS, RN</last_name>
    <role>Study Director</role>
    <affiliation>Senior Manager Clinical Affairs</affiliation>
  </overall_official>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>November 13, 2018</last_update_submitted>
  <last_update_submitted_qc>November 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03030872
org study id: AD0542
nct id: NCT03030872
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The objective of this study is to compare the diagnostic value of MR DSC-Perfusion (Perfusion
      Module), MR DWI (Diffusion Module) and MR DTI (Diffusion Module) in CARESTREAM Vue PACS
      ("investigational device") to the Olea Sphere PACS with Perfusion and DWI Modules ("predicate
      device"). Therefore, there will be several separate objectives depending on the type of
      acquisition:
Carestream Health, Inc. will investigate the imaging performance of the CARESTREAM Vue PACS
      v12.2 Magnetic Resonance (MR) Perfusion and Diffusion Weighted Imaging ("investigational
      device") performance. Evaluation of MR Dynamic Susceptibility Contrast-Enhanced Perfusion
      Weighted Imaging (DSC-Perfusion), MR Diffusion Weighted Imaging (DWI) and MR Diffusion Tensor
      Imaging (DTI) was compared to the predicate device, the Olea Sphere PACS with Perfusion and
      DWI Modules. MR DSC-Perfusion of the brain is a method for evaluating blood flow in the brain
      and producing optimized parametric maps that help visualize this blood flow. MR DWI is a
      method to evaluate the motion of water molecules within bodily tissues. MR DTI is an
      extension of DWI that allows extraction of the diffusion tensor. The purpose of this study is
      to demonstrate equivalent clinical quality between the investigational and predicate devices
      using a radiologist evaluation of key metrics which are applicable to MR DSC-Perfusion, MR
      DWI, and MR DTI images.
observational model: Case-Only
time perspective: Retrospective
measure: Diagnostic value comparison of Carestream Vue PACS v12.2 MR Perfusion and Diffusion (investigational software) images to the Olea Shere PACS with Perfusion and DWI Modules (predicate software) images.
time frame: January 2017
description: Diagnostic value of investigational images compared to the diagnostic value of predicate images as assessed by a radiologist evaluation of key metrics.
arm group label: Predicate software
description: Olea Sphere PACS with Perfusion and DWI Modules
arm group label: Investigational software
description: Vue PACS v12.2 Magnetic Resonance (MR) Perfusion and Diffusion Weighted Imaging
intervention type: Device
intervention name: Investigational software
description: The study evaluated retrospective de-identified cases that were processed after the imaging procedure had been completed (off-line) using a dedicated workstation.
arm group label: Investigational software
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Susan Pate, MS, RN
role: Study Director
affiliation: Senior Manager Clinical Affairs
responsible party type: Sponsor
mesh term: Ischemia
sharing ipd: No