<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/NCT02999490</url>
  </required_header>
  <id_info>
    <org_study_id>HYXK0001</org_study_id>
    <nct_id>NCT02999490</nct_id>
  </id_info>
  <brief_title>18F-FDG PET/CT in Diagnostic Patients of Disorder of Consciousness</brief_title>
  <official_title>18F-FDG PET/CT in Diagnostic Patients of Disorder of Consciousness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou General Hospital of Guangzhou Military Command</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou General Hospital of Guangzhou Military Command</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical examinations are difficult to discriminate between vegetative state and minimally&#xD;
      conscious state. the diagnostic and prognostic usefulness of neuroimaging methods has not&#xD;
      been established in a clinical setting. we will do a forward study of PET imaging in&#xD;
      disorders of consciousness patients, and validate with clinical assessments with the coma&#xD;
      recovery Scale-Revised(CRS-R).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Every patient need to be conducted the PET/CT scanning two times.The first time is resting&#xD;
      state.The second time is stimulated state by watching a vedio.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">December 5, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>standardized uptake value</measure>
    <time_frame>60 mins after injecting 18F-FDG</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Persistent Vegetative State</condition>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The controls are intravenous injected of 185 to 370 MBq 18F-FDG.Then,the controls sleep for an hour in a quiet room before scanning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients are intravenous injected of 185 to 370 MBq 18F-FDG.Then,the patients sleep for an hour in a quiet room before scanning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>18F-FDG</intervention_name>
    <description>18F-FDG is positron emission tomography imaging agent which is already widely used in PET/CT examination.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of disorder of consciousness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yin Jilin</last_name>
    <role>Study Director</role>
  </overall_official>
  <location>
    <facility>
      <name>The PET/CT Centre Guangzhou General Hospital of Guangzhou Military Command</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>March 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>April 19, 2018</last_update_submitted>
  <last_update_submitted_qc>April 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou General Hospital of Guangzhou Military Command</investigator_affiliation>
    <investigator_full_name>Jing Zhao</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Consciousness Disorders</mesh_term>
    <mesh_term>Persistent Vegetative State</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
  </intervention_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/NCT02999490
org study id: HYXK0001
nct id: NCT02999490
lead sponsor: 
has dmc: No
Clinical examinations are difficult to discriminate between vegetative state and minimally
      conscious state. the diagnostic and prognostic usefulness of neuroimaging methods has not
      been established in a clinical setting. we will do a forward study of PET imaging in
      disorders of consciousness patients, and validate with clinical assessments with the coma
      recovery Scale-Revised(CRS-R).
Every patient need to be conducted the PET/CT scanning two times.The first time is resting
      state.The second time is stimulated state by watching a vedio.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: standardized uptake value
time frame: 60 mins after injecting 18F-FDG
arm group label: Controls
arm group type: No Intervention
description: The controls are intravenous injected of 185 to 370 MBq 18F-FDG.Then,the controls sleep for an hour in a quiet room before scanning.
arm group label: Patients
arm group type: Experimental
description: The patients are intravenous injected of 185 to 370 MBq 18F-FDG.Then,the patients sleep for an hour in a quiet room before scanning.
intervention type: Radiation
intervention name: 18F-FDG
description: 18F-FDG is positron emission tomography imaging agent which is already widely used in PET/CT examination.
arm group label: Patients
criteria: 
gender: All
minimum age: 10 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yin Jilin
role: Study Director
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou General Hospital of Guangzhou Military Command
investigator full name: Jing Zhao
investigator title: Clinical Professor
mesh term: Consciousness Disorders
mesh term: Persistent Vegetative State
mesh term: Fluorodeoxyglucose F18
sharing ipd: Yes