xml: <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/NCT06027021</url>
    </required_header>
    <id_info>
      <org_study_id>ARTE-MISO</org_study_id>
      <nct_id>NCT06027021</nct_id>
    </id_info>
    <brief_title>Assessment of Hypoxia Before Radioembolization Treatment With 18F-FMISO PET</brief_title>
    <acronym>ARTE-MISO</acronym>
    <official_title>Assessment of Hypoxia Before Radioembolization Treatment With 18F-FMISO PET</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara University</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>
        Hypoxia is a known factor for resistance to radiotherapy in tumors. Response to transarterial&#xD;
        radioembolization is known to be variable between different patients even if the same dose of&#xD;
        radiation was delivered. In this study the investigators aim to quantify the hypoxia in the&#xD;
        primary and secondary tumors of liver with 18F-FMISO PET before radioembolization and to&#xD;
        prove any effect of the hypoxia, if present, on the dose that should be delivered to tumor to&#xD;
        ensure treatment response.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 15, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Demonstrate the effect of the hypoxia in the success of the radioembolization treatment</measure>
      <time_frame>08/2024</time_frame>
      <description>Demonstrate the effect of the hypoxia in the success of the radioembolization treatment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group.</measure>
      <time_frame>08/2024</time_frame>
      <description>The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Radioembolization</condition>
    <condition>Radiotherapy</condition>
    <condition>Cancer</condition>
    <condition>Positron Emission Tomography</condition>
    <arm_group>
      <arm_group_label>Treatment group</arm_group_label>
      <description>Patients received radioembolization with hepatocellular cancer or colorectal cancer liver metastases</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>18F-Fluoromisonidazole PET</intervention_name>
      <description>Imaging of hypoxia before radioembolization with 18F-Fluoromisonidazole PET.</description>
      <arm_group_label>Treatment group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The patients with hepatocellular carcinoma or colorectal carcinoma with liver metastasis&#xD;
          who are referred for transarterial radioembolization to Ankara University School of&#xD;
          Medicine Department of Nuclear Medicine will be enrolled for the trial.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with colorectal carcinoma with liver metastasis or hepatocellular carcinoma.&#xD;
  &#xD;
            -  Is not eligible for surgery&#xD;
  &#xD;
            -  Above 18 years old&#xD;
  &#xD;
            -  The patients who are referred for transarterial radioembolization treatment to Ankara&#xD;
               University School of Medicine Department of Nuclear Medicine.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with ECOG performance score &gt;1&#xD;
  &#xD;
            -  Claustrophobia&#xD;
  &#xD;
            -  Life expectancy shorter than 3 months&#xD;
  &#xD;
            -  Pregnant or breast-feeding patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Cigdem Soydal, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ankara University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cigdem Soydal, MD</last_name>
      <phone>903125956445</phone>
      <email>csoydal@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ankara University</name>
        <address>
          <city>Ankara</city>
          <zip>06590</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cigdem Soydal, MD</last_name>
        <phone>903125956445</phone>
        <email>csoydal@yahoo.com</email>
      </contact>
      <investigator>
        <last_name>Cigdem Soydal, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ankara University</investigator_affiliation>
      <investigator_full_name>Cigdem Soydal</investigator_full_name>
      <investigator_title>Asc Prof</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypoxia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027021
  org study id: ARTE-MISO
  nct id: NCT06027021
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Hypoxia is a known factor for resistance to radiotherapy in tumors. Response to transarterial
        radioembolization is known to be variable between different patients even if the same dose of
        radiation was delivered. In this study the investigators aim to quantify the hypoxia in the
        primary and secondary tumors of liver with 18F-FMISO PET before radioembolization and to
        prove any effect of the hypoxia, if present, on the dose that should be delivered to tumor to
        ensure treatment response.
  observational model: Cohort
  time perspective: Prospective
  measure: Demonstrate the effect of the hypoxia in the success of the radioembolization treatment
  time frame: 08/2024
  description: Demonstrate the effect of the hypoxia in the success of the radioembolization treatment
  measure: The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group.
  time frame: 08/2024
  description: The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group.
  arm group label: Treatment group
  description: Patients received radioembolization with hepatocellular cancer or colorectal cancer liver metastases
  intervention type: Diagnostic Test
  intervention name: 18F-Fluoromisonidazole PET
  description: Imaging of hypoxia before radioembolization with 18F-Fluoromisonidazole PET.
  arm group label: Treatment group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Cigdem Soydal, MD
  role: Principal Investigator
  affiliation: Ankara University
  last name: Cigdem Soydal, MD
  phone: 903125956445
  email: csoydal@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ankara University
  investigator full name: Cigdem Soydal
  investigator title: Asc Prof
  mesh term: Hypoxia