<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/NCT03040453</url>
  </required_header>
  <id_info>
    <org_study_id>EPN 2016/2212-31/2</org_study_id>
    <nct_id>NCT03040453</nct_id>
  </id_info>
  <brief_title>Immunological Response After Ablative Therapy in the Liver</brief_title>
  <acronym>IRAL</acronym>
  <official_title>Comparison of Immunological Response After Microwave Ablation and Irreversible Electroporation of Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</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>
      Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not&#xD;
      eligible for liver transplant or liver resection. At our Hospital two different methods are&#xD;
      used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible&#xD;
      electroporation, where the tumor cells are exposed to an electrical field and nano-pores are&#xD;
      formed in the cell membranes and the cells go into apoptosis (programed cell death).&#xD;
&#xD;
      Previous studies have shown effects on the immune system after ablative therapies.&#xD;
&#xD;
      The purpose of this study is to compare the immunological response after the wo different&#xD;
      methods of killing the tumor cells.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    poor recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2018</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immunological response</measure>
    <time_frame>Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90</time_frame>
    <description>Change in immunological response</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months.</measure>
    <time_frame>Follow-up every three months for one year with CT scan.</time_frame>
    <description>Compare the effect of the two different ablative methods</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Immune Response</condition>
  <arm_group>
    <arm_group_label>Microwave ablation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>20 patients will be treated with microwave ablation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Irreversible electroporation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>20 patients will be treated with irreversible electroporation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microwave ablation</intervention_name>
    <arm_group_label>Microwave ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Irreversible electroporation</intervention_name>
    <arm_group_label>Irreversible electroporation</arm_group_label>
    <other_name>Nano Knife, Angiodynamics</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hepatocellular carcinoma, maximum 3 lesions, maximum 30 mm in any cross section&#xD;
             diameter&#xD;
&#xD;
          -  Physically fit to undergo general anaesthesia&#xD;
&#xD;
          -  Fully understand swedish instructions regarding the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atrial fibrillation (for irreversible electroporation)&#xD;
&#xD;
          -  Pacemaker (for irreversible electroporation)&#xD;
&#xD;
          -  &gt;3 lesions&#xD;
&#xD;
          -  &gt; 30 mm in any cross section diameter&#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>Jacob Freedman, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Instituet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Surgery and Urology, Danderyd Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>18288</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>November 26, 2020</last_update_submitted>
  <last_update_submitted_qc>November 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Irreversible electroporation</keyword>
  <keyword>Microwave ablation</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>
  <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/NCT03040453
org study id: EPN 2016/2212-31/2
nct id: NCT03040453
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not
      eligible for liver transplant or liver resection. At our Hospital two different methods are
      used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible
      electroporation, where the tumor cells are exposed to an electrical field and nano-pores are
      formed in the cell membranes and the cells go into apoptosis (programed cell death).

      Previous studies have shown effects on the immune system after ablative therapies.

      The purpose of this study is to compare the immunological response after the wo different
      methods of killing the tumor cells.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Immunological response
time frame: Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90
description: Change in immunological response
measure: Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months.
time frame: Follow-up every three months for one year with CT scan.
description: Compare the effect of the two different ablative methods
arm group label: Microwave ablation
arm group type: Other
description: 20 patients will be treated with microwave ablation
arm group label: Irreversible electroporation
arm group type: Other
description: 20 patients will be treated with irreversible electroporation
intervention type: Device
intervention name: Microwave ablation
arm group label: Microwave ablation
intervention type: Device
intervention name: Irreversible electroporation
arm group label: Irreversible electroporation
other name: Nano Knife, Angiodynamics
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jacob Freedman, MD, PhD
role: Principal Investigator
affiliation: Karolinska Instituet
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No