<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/NCT02971917</url>
  </required_header>
  <id_info>
    <org_study_id>SNUHTruviewART-001</org_study_id>
    <nct_id>NCT02971917</nct_id>
  </id_info>
  <brief_title>A Clinical Study of TRUVIEW ART™(Advanced Reconstruction Tech)to Improve Image Quality on Chest Radiograph</brief_title>
  <acronym>ART</acronym>
  <official_title>A Clinical Study of TRUVIEW ART(Advanced Reconstruction Tech)to Improve Image Quality on Chest Radiograph</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To validate the following theory: &quot;With TRUVIEW ART™ applied a detector's quantitative&#xD;
      performance index, MTF(Modulation Transfer Function), is increased 20% or more&quot;. This is to&#xD;
      examine the effect of the increased MTF index, whether it influences or not the interpreter's&#xD;
      preference&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background of Study :&#xD;
&#xD;
      DRTECH Corp. has developed and applied for patenting the unique technology of TRUVIEW ART™.&#xD;
      TRUVIEW ART™ is advanced image reconstruction technology that restores image quality from the&#xD;
      side effects of scattering signals in indirect type scintillator detectors. It is an advanced&#xD;
      image pre-processing technology that constructs signal scattering models (PSF) of indirect&#xD;
      type detector scintillators. Image sharpness (MTF) is improved by predicting scattering&#xD;
      models and eliminating the scattering signal.&#xD;
&#xD;
      Purpose of Research and Assumption :&#xD;
&#xD;
      Indirect conversion type detectors using scintillators are universal in today's diagnostic&#xD;
      imaging area. However, they have a disadvantage of signal scattering compared with direct&#xD;
      conversion type detectors. TRUVIEW ART™(Advanced Reconstruction Technology) can restore&#xD;
      images from the scattering problems. The purpose of this study is to verify how well it&#xD;
      improves the usefulness in clinical diagnostic imaging. Evaluation will measure the&#xD;
      improvements in MTF, which is the quantitative performance index of a detector.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative research using Wilcoxon's signed rank test to compare images produced by test equipment before and after applying TRUVIEW ART (Advanced Reconstruction Tech)</measure>
    <time_frame>Report composed based on analysis of clinical images accumulated over 6 months</time_frame>
    <description>- Preference score : Eleven anatomic regions(unobscured lung, hilum, minor fissure, retrocardiac lung, lung projected below the diaphragm (subdiaphragmatic lung), azygoesophageal recess, heart border, rib, proximal airway, thoracic spine, and overall appearance) are evaluated. Each pair of images is ranked on a scale from one to five</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Thoracic Diseases</condition>
  <arm_group>
    <arm_group_label>Clinical study of TRUVIEW ART</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chest x-ray image acquisition Creation of TRUVIEW ART applied image Comparison of TRUVIEW ART image with original image</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Chest x-ray image acquisition</intervention_name>
    <description>Obtain a digital X-ray chest image of the patient</description>
    <arm_group_label>Clinical study of TRUVIEW ART</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Creation of TRUVIEW ART applied image</intervention_name>
    <description>Application of TRUVIEW ART to the original chest x-ray image to create a new set of TRUVIEW ART applied image.&#xD;
Outcome: 2 versions of chest image&#xD;
Original Chest X-ray (w/o TRUVIEW ART)&#xD;
TRUVIEW ART applied image</description>
    <arm_group_label>Clinical study of TRUVIEW ART</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Comparison of TRUVIEW ART image with original image</intervention_name>
    <description>Comparison of 2 versions of chest image side by side Performance evaluation may consist of detailed categories such as expression of chest structure, visibility level of pulmonary vascular system, etc. For all categories visibility and preference will be scored and each category will be analyzed to point out any statistical difference</description>
    <arm_group_label>Clinical study of TRUVIEW ART</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults of age 20 or higher&#xD;
&#xD;
          -  Person who is able to fully understand the clinical research procedures&#xD;
&#xD;
          -  Signed up agreement form&#xD;
&#xD;
          -  Patient who visits for Chest computed tomography (CT)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is pregnant or suspicious of being pregnant&#xD;
&#xD;
          -  Not able or willing to provide Informed Consent, or consent is withdrawn&#xD;
&#xD;
          -  Not able to collect all required case information&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Mo Goo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Radiology, Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin Mo Goo, M.D.</last_name>
    <phone>82-2-2072-2584</phone>
    <email>jmgoo@plaza.snu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Su Yeon Ahn, M.D.</last_name>
      <phone>82-2-2072-2254</phone>
      <email>ddodola323@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin Mo Goo</investigator_full_name>
    <investigator_title>Professor, Department of Radiology</investigator_title>
  </responsible_party>
  <keyword>Chest radiography</keyword>
  <keyword>Image improvements</keyword>
  <keyword>Image Reconstruction</keyword>
  <keyword>Preprocessing</keyword>
  <keyword>MTF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thoracic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02971917
org study id: SNUHTruviewART-001
nct id: NCT02971917
lead sponsor: 
has dmc: No
To validate the following theory: "With TRUVIEW ART™ applied a detector's quantitative
      performance index, MTF(Modulation Transfer Function), is increased 20% or more". This is to
      examine the effect of the increased MTF index, whether it influences or not the interpreter's
      preference
Background of Study :

      DRTECH Corp. has developed and applied for patenting the unique technology of TRUVIEW ART™.
      TRUVIEW ART™ is advanced image reconstruction technology that restores image quality from the
      side effects of scattering signals in indirect type scintillator detectors. It is an advanced
      image pre-processing technology that constructs signal scattering models (PSF) of indirect
      type detector scintillators. Image sharpness (MTF) is improved by predicting scattering
      models and eliminating the scattering signal.

      Purpose of Research and Assumption :

      Indirect conversion type detectors using scintillators are universal in today's diagnostic
      imaging area. However, they have a disadvantage of signal scattering compared with direct
      conversion type detectors. TRUVIEW ART™(Advanced Reconstruction Technology) can restore
      images from the scattering problems. The purpose of this study is to verify how well it
      improves the usefulness in clinical diagnostic imaging. Evaluation will measure the
      improvements in MTF, which is the quantitative performance index of a detector.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Qualitative research using Wilcoxon's signed rank test to compare images produced by test equipment before and after applying TRUVIEW ART (Advanced Reconstruction Tech)
time frame: Report composed based on analysis of clinical images accumulated over 6 months
description: - Preference score : Eleven anatomic regions(unobscured lung, hilum, minor fissure, retrocardiac lung, lung projected below the diaphragm (subdiaphragmatic lung), azygoesophageal recess, heart border, rib, proximal airway, thoracic spine, and overall appearance) are evaluated. Each pair of images is ranked on a scale from one to five
arm group label: Clinical study of TRUVIEW ART
arm group type: Experimental
description: Chest x-ray image acquisition Creation of TRUVIEW ART applied image Comparison of TRUVIEW ART image with original image
intervention type: Radiation
intervention name: Chest x-ray image acquisition
description: Obtain a digital X-ray chest image of the patient
arm group label: Clinical study of TRUVIEW ART
intervention type: Radiation
intervention name: Creation of TRUVIEW ART applied image
description: Application of TRUVIEW ART to the original chest x-ray image to create a new set of TRUVIEW ART applied image.
Outcome: 2 versions of chest image
Original Chest X-ray (w/o TRUVIEW ART)
TRUVIEW ART applied image
arm group label: Clinical study of TRUVIEW ART
intervention type: Radiation
intervention name: Comparison of TRUVIEW ART image with original image
description: Comparison of 2 versions of chest image side by side Performance evaluation may consist of detailed categories such as expression of chest structure, visibility level of pulmonary vascular system, etc. For all categories visibility and preference will be scored and each category will be analyzed to point out any statistical difference
arm group label: Clinical study of TRUVIEW ART
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jin Mo Goo, M.D.
role: Principal Investigator
affiliation: Department of Radiology, Seoul National University Hospital
last name: Jin Mo Goo, M.D.
phone: 82-2-2072-2584
email: jmgoo@plaza.snu.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin Mo Goo
investigator title: Professor, Department of Radiology
mesh term: Thoracic Diseases
sharing ipd: Yes