<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/NCT03793322</url>
  </required_header>
  <id_info>
    <org_study_id>201803</org_study_id>
    <nct_id>NCT03793322</nct_id>
  </id_info>
  <brief_title>The Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma</brief_title>
  <official_title>The Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhujiang Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence&#xD;
      imaging in the detection of liver tumors. By correlating the ICG fluorescence patterns with&#xD;
      pathologically confirmed tumors , it would be possible to use fluorescence navigation system&#xD;
      in helping promoting oncology treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</primary_completion_date>
  <phase>Phase 1</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>The accuracy of detecting small liver tumor by ICG fluorescence.</measure>
    <time_frame>3 Days</time_frame>
    <description>The tumor which aggregate ICG fluorescence will be resected and dignosed by pathology. The accuracy of detecting small liver tumor by ICG fluorescence will be evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The accuracy of positive margins of resection detected by ICG fluorescence.</measure>
    <time_frame>3 Days</time_frame>
    <description>The surgery margins will be detected by ICG fluorescence. If there is fluorescence aggregating, we consider the presence of residual tumor in the margin and proven by histological examination.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Indocyanine-Green(ICG) injection group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indocyanine-Green(ICG)</intervention_name>
    <description>ICG was administered intravenously 24 hours before the operation , or directly into the portal vein branches supplying the tumor-bearing hepatic segment, after puncturing of the target segments under intraoperative ultrasonography guidance.</description>
    <arm_group_label>Indocyanine-Green(ICG) injection group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years≤ Age ≤70 years&#xD;
&#xD;
          -  Compling with the diagnosis criteria of hepatic carcinoma.&#xD;
&#xD;
          -  Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer&#xD;
             metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled.&#xD;
&#xD;
          -  Preoperative liver function is Child - Pugh grade A or B.&#xD;
&#xD;
          -  The patients are volunteered for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with mental illness.&#xD;
&#xD;
          -  Patients can't tolerate the operation owe to a variety of basic diseases (such as&#xD;
             severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system&#xD;
             diseases, etc.&#xD;
&#xD;
          -  The patients refused to take part in the study.&#xD;
&#xD;
          -  There are other co-existed malignant tumors.&#xD;
&#xD;
          -  Benign liver diseases.&#xD;
&#xD;
          -  Indocyanine green allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chihua Fang</last_name>
    <role>Principal Investigator</role>
    <affiliation>China, Guangdong Zhujiang Hospital of The Southern Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chihua Fang, MD; PHD</last_name>
    <phone>+8613609700805</phone>
    <email>fangch_dr@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhujiang Hospital of Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510282</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chihua Fang, MD</last_name>
      <phone>(+86)2062782568</phone>
      <email>s_mountain@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Qingshan Chen, MM</last_name>
      <phone>(+86)2062782568</phone>
      <email>s_mountain@126.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>Indocyanine-Green(ICG)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</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/NCT03793322
org study id: 201803
nct id: NCT03793322
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence
      imaging in the detection of liver tumors. By correlating the ICG fluorescence patterns with
      pathologically confirmed tumors , it would be possible to use fluorescence navigation system
      in helping promoting oncology treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The accuracy of detecting small liver tumor by ICG fluorescence.
time frame: 3 Days
description: The tumor which aggregate ICG fluorescence will be resected and dignosed by pathology. The accuracy of detecting small liver tumor by ICG fluorescence will be evaluated.
measure: The accuracy of positive margins of resection detected by ICG fluorescence.
time frame: 3 Days
description: The surgery margins will be detected by ICG fluorescence. If there is fluorescence aggregating, we consider the presence of residual tumor in the margin and proven by histological examination.
arm group label: Indocyanine-Green(ICG) injection group
arm group type: Experimental
intervention type: Drug
intervention name: Indocyanine-Green(ICG)
description: ICG was administered intravenously 24 hours before the operation , or directly into the portal vein branches supplying the tumor-bearing hepatic segment, after puncturing of the target segments under intraoperative ultrasonography guidance.
arm group label: Indocyanine-Green(ICG) injection group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chihua Fang
role: Principal Investigator
affiliation: China, Guangdong Zhujiang Hospital of The Southern Medical University
last name: Chihua Fang, MD; PHD
phone: +8613609700805
email: fangch_dr@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular