<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/NCT03754192</url>
  </required_header>
  <id_info>
    <org_study_id>APHP180011</org_study_id>
    <nct_id>NCT03754192</nct_id>
  </id_info>
  <brief_title>Perfusion and Dual Energy Computer Tomography in Hepatocellular Carcinoma</brief_title>
  <acronym>PERCAHEC</acronym>
  <official_title>Prediction Value of Perfusion and Dual Energy Computer Tomography for Microvascular Invasion in Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the hepatic perfusion computer tomography and dual&#xD;
      energy computer tomography in the assessment of tumor characterization of Hepatocellular&#xD;
      carcinoma in patients with resectable Hepatocellular carcinoma by comparing the quantitative&#xD;
      parameters computer tomography obtained with the pathological data of the surgical specimens.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dual-energy computer tomography and perfusion computer tomography (General Electric&#xD;
      revolution Hight definition Gemstone™ Spectral Imaging) will be performed in all patients.&#xD;
      Iodine concentration and quantitative perfusion parameters of the Hepatocellular carcinoma&#xD;
      and surrounding liver parenchyma data will be compared with the pathological results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>
    <intervention_model_description>Dual-energy computed tomography and perfusion computed tomography</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pefusion parameters</measure>
    <time_frame>5 minutes</time_frame>
    <description>correlation between pre-operative imaging data and histological data of Hepatocellular carcinoma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pathological examination</measure>
    <time_frame>1 month</time_frame>
    <description>Compare data obtained in perfusion computer tomography to the imaging data and to the Histological differentiation grades</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>perfusion computed tomography</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Will be realsed before liver surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>perfusion Computed Tomography</intervention_name>
    <description>Will be carried before liver surgery</description>
    <arm_group_label>perfusion computed tomography</arm_group_label>
    <other_name>Computed tomography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of Hepatocellular carcinoma made according to the guidelines of the&#xD;
             American Association for the study of the Liver&#xD;
&#xD;
          -  Affiliation to a national health insurance&#xD;
&#xD;
          -  An indication for hepatic resection during the decision-making stage&#xD;
&#xD;
          -  A request for a pre-operative Computer Tomography in our radiology unit&#xD;
&#xD;
          -  An affiliation to a social security&#xD;
&#xD;
          -  Informed consent given by the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatments of Hepatocellular carcinoma (medicated or surgical)&#xD;
&#xD;
          -  Patient under tutorship or curatorship&#xD;
&#xD;
          -  Pregnant or lactating woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LEWIN MAITE, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>LEWIN MAITE, MD, Phd</last_name>
    <phone>00 (33) 6 11 15 06 17</phone>
    <email>maite.lewin@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>DA-MOTA-FERREIRA Jean-Manuel, Radiologic</last_name>
    <phone>00 (33) 145592474</phone>
    <email>jean-manuel.da-mota-ferreira@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Paul Brousse</name>
      <address>
        <city>Villejuif</city>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>LEWIN MAITE, MD, PhD</last_name>
      <phone>00 (33) 6 11 15 06 17</phone>
      <email>maite.lewin@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Perfusion computer tomography</keyword>
  <keyword>dual-energy computer tomography</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/NCT03754192
org study id: APHP180011
nct id: NCT03754192
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the hepatic perfusion computer tomography and dual
      energy computer tomography in the assessment of tumor characterization of Hepatocellular
      carcinoma in patients with resectable Hepatocellular carcinoma by comparing the quantitative
      parameters computer tomography obtained with the pathological data of the surgical specimens.
Dual-energy computer tomography and perfusion computer tomography (General Electric
      revolution Hight definition Gemstone™ Spectral Imaging) will be performed in all patients.
      Iodine concentration and quantitative perfusion parameters of the Hepatocellular carcinoma
      and surrounding liver parenchyma data will be compared with the pathological results.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Dual-energy computed tomography and perfusion computed tomography
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pefusion parameters
time frame: 5 minutes
description: correlation between pre-operative imaging data and histological data of Hepatocellular carcinoma
measure: Pathological examination
time frame: 1 month
description: Compare data obtained in perfusion computer tomography to the imaging data and to the Histological differentiation grades
arm group label: perfusion computed tomography
arm group type: Other
description: Will be realsed before liver surgery
intervention type: Radiation
intervention name: perfusion Computed Tomography
description: Will be carried before liver surgery
arm group label: perfusion computed tomography
other name: Computed tomography
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: LEWIN MAITE, MD, PhD
role: Principal Investigator
affiliation: APHP
last name: LEWIN MAITE, MD, Phd
phone: 00 (33) 6 11 15 06 17
email: maite.lewin@aphp.fr
last name: DA-MOTA-FERREIRA Jean-Manuel, Radiologic
phone: 00 (33) 145592474
email: jean-manuel.da-mota-ferreira@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular