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/NCT06030232</url>
    </required_header>
    <id_info>
      <org_study_id>TACOME-TR</org_study_id>
      <nct_id>NCT06030232</nct_id>
    </id_info>
    <brief_title>Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver</brief_title>
    <acronym>TACOME</acronym>
    <official_title>Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Boston Scientific Corporation</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </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>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Radioembolization is an established treatment option for patients with unresectable primary&#xD;
        and secondary liver tumors. Microspheres containing 90Y are injected intraarterially to&#xD;
        deliver a high radiation dose to the tumors. Despite of our knowledge on the effectiveness of&#xD;
        90Y glass microspheres in the treatment of HCC, literature data on the treatment of&#xD;
        metastatic colorectal cancer (mCRC) patients with 90Y glass microspheres is limited. In the&#xD;
        recent EANM guideline variable healthy liver doses are recommended for patients with mCRC&#xD;
        with an effective tumor dose recommendation based on a study with limited number of patients.&#xD;
  &#xD;
        Primary objectives; Investigate effective tumor dose and safe healthy liver dose in&#xD;
        radioembolization for colorectal cancer liver metastasis using multicompartment dosimetry&#xD;
        Secondary objectives; Investigate dose-response and dose-toxicity relationships, time to&#xD;
        progress, concordance between pretreatment and posttreatment dose calculations.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">June 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>effective tumor dose and safe healthy liver dose</measure>
      <time_frame>3th month after treatment</time_frame>
      <description>Compare the mean effective tumor doses effective tumour dose (in Gy) of patients with or without response to radioembolization for colorectal cancer liver metastasis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>dose (in Gy) -response and dose (in Gy)-toxicity relationships</measure>
      <time_frame>6th month after treatment</time_frame>
      <description>Investigate dose-response and dose-toxicity relationships after transarterial radioembolization.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Transarterial Radioembolization</condition>
    <arm_group>
      <arm_group_label>Observation group</arm_group_label>
      <description>Patients who received radioembolization for colorectal cancer liver metastases</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Therasphere</intervention_name>
      <description>Transarterial radioembolization</description>
      <arm_group_label>Observation group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients with metastatic colorectal cancer (mCRC) treated using Y90 glass&#xD;
          microspheres in lobar or segmental fashion&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  over 18 years old&#xD;
  &#xD;
            -  histopathologically proven colorectal cancer diagnosis&#xD;
  &#xD;
            -  treated with radioembolization for liver metastases with Y90 glass microspheres in&#xD;
               lobar or segmental fashion&#xD;
  &#xD;
            -  have follow-up data at least 6 months after radioembolization&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  no PET-CT, CT or MR of the liver within last 6 weeks prior to radioembolization.&#xD;
  &#xD;
          No PET-CT, CT or MR of the liver 2-4 months after radioembolization Poor image quality&#xD;
          Previous local treatment or surgery for the liver&#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_contact>
      <last_name>Cigdem Soydal, Asc Prof</last_name>
      <phone>+903125956445</phone>
      <email>csoydal@yahoo.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 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 8, 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. of Nuclear Medicine, MD, FEBNM</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasm Metastasis</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/NCT06030232
  org study id: TACOME-TR
  nct id: NCT06030232
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Radioembolization is an established treatment option for patients with unresectable primary
        and secondary liver tumors. Microspheres containing 90Y are injected intraarterially to
        deliver a high radiation dose to the tumors. Despite of our knowledge on the effectiveness of
        90Y glass microspheres in the treatment of HCC, literature data on the treatment of
        metastatic colorectal cancer (mCRC) patients with 90Y glass microspheres is limited. In the
        recent EANM guideline variable healthy liver doses are recommended for patients with mCRC
        with an effective tumor dose recommendation based on a study with limited number of patients.
  
        Primary objectives; Investigate effective tumor dose and safe healthy liver dose in
        radioembolization for colorectal cancer liver metastasis using multicompartment dosimetry
        Secondary objectives; Investigate dose-response and dose-toxicity relationships, time to
        progress, concordance between pretreatment and posttreatment dose calculations.
  observational model: Cohort
  time perspective: Retrospective
  measure: effective tumor dose and safe healthy liver dose
  time frame: 3th month after treatment
  description: Compare the mean effective tumor doses effective tumour dose (in Gy) of patients with or without response to radioembolization for colorectal cancer liver metastasis.
  measure: dose (in Gy) -response and dose (in Gy)-toxicity relationships
  time frame: 6th month after treatment
  description: Investigate dose-response and dose-toxicity relationships after transarterial radioembolization.
  arm group label: Observation group
  description: Patients who received radioembolization for colorectal cancer liver metastases
  intervention type: Device
  intervention name: Therasphere
  description: Transarterial radioembolization
  arm group label: Observation group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Cigdem Soydal, Asc Prof
  phone: +903125956445
  email: csoydal@yahoo.com
  responsible party type: Principal Investigator
  investigator affiliation: Ankara University
  investigator full name: Cigdem Soydal
  investigator title: Asc. Prof. of Nuclear Medicine, MD, FEBNM
  mesh term: Neoplasm Metastasis