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/NCT06013774</url>
    </required_header>
    <id_info>
      <org_study_id>NL71365.041.20</org_study_id>
      <nct_id>NCT06013774</nct_id>
    </id_info>
    <brief_title>Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure</brief_title>
    <acronym>IXSI</acronym>
    <official_title>Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>UMC Utrecht</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>UMC Utrecht</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To establish the safety and feasibility of interventional x-ray and scintigraphy imaging&#xD;
        during the pre-treatment procedure of hepatic radioembolization&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 25, 2021</start_date>
    <completion_date type="Actual">January 16, 2023</completion_date>
    <primary_completion_date type="Actual">January 16, 2023</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>
      <primary_purpose>Device Feasibility</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Device Feasibility</measure>
      <time_frame>Immediately after surgery</time_frame>
      <description>The feasibility of IXSI will be assessed by questionnaires filled in by interventional radiology personnel</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Radioactivity distribution over time</measure>
      <time_frame>Immediately after surgery</time_frame>
      <description>The radioactivity distribution in the liver segments will be measured over time to assess potential dynamic behavior</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Radioactivity distribution in 3D</measure>
      <time_frame>Immediately after surgery</time_frame>
      <description>The quality of IXSI scans will be assessed by measuring the radioactivity distribution in the liver segments in 3D</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">12</enrollment>
    <condition>Liver Cancer</condition>
    <arm_group>
      <arm_group_label>Hybrid imaging during the pre-treatment procedure of radioembolization</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Hybrid imaging will be performed on patients undergoing the pre-treatment procedure of radioembolization</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>IXSI</intervention_name>
      <description>Hybrid imaging with IXSI will be performed during the radioembolization pre-treatment procedure</description>
      <arm_group_label>Hybrid imaging during the pre-treatment procedure of radioembolization</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participants must have given written informed consent and comply with the requirements&#xD;
               of the study protocol.&#xD;
  &#xD;
            2. Must be aged 18 years or over.&#xD;
  &#xD;
            3. Must be selected to undergo a 99mTc-MAA procedure as part of their radioembolisation&#xD;
               treatment.&#xD;
  &#xD;
            4. Sufficiently fit to undergo an additional examination time of 30-90 minutes.&#xD;
  &#xD;
            5. Have a CT acquired less than 6 weeks before the pre-treatment radioembolisation&#xD;
               procedure.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients expected to require more than two injection positions for radioembolisation&#xD;
               treatment.&#xD;
  &#xD;
            2. Pregnancy or nursing.&#xD;
  &#xD;
            3. Patients suffering from psychic disorders that make a comprehensive judgement&#xD;
               impossible, such as psychosis, hallucinations and/or depression.&#xD;
  &#xD;
            4. Patients who are declared incompetent.&#xD;
  &#xD;
            5. Previous enrollment in the present study&#xD;
  &#xD;
            6. Claustrophobia&#xD;
  &#xD;
            7. The last dose of prior chemotherapy has been received less than weeks prior to the&#xD;
               planned 99mTc-MAA pre-treatment procedure.&#xD;
  &#xD;
            8. Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pre-treatment&#xD;
               procedure&#xD;
  &#xD;
            9. Major surgery within the last 4 weeks prior to the planned 99mTc-MAA pre-treatment&#xD;
               procedure&#xD;
  &#xD;
           10. Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events&#xD;
               (CTCAE version 5) grade 2 from previous anti-cancer treatment&#xD;
  &#xD;
           11. Body weight over 250 kg (because of maximum table load)&#xD;
  &#xD;
           12. Patient length over 1.90 m (to fit IXSI geometry)&#xD;
  &#xD;
           13. Patient bust line over 135 cm (to fit IXSI geometry)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>UMC Utrecht</name>
        <address>
          <city>Utrecht</city>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>UMC Utrecht</investigator_affiliation>
      <investigator_full_name>Hugo de Jong</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Neoplasms</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/NCT06013774
  org study id: NL71365.041.20
  nct id: NCT06013774
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To establish the safety and feasibility of interventional x-ray and scintigraphy imaging
        during the pre-treatment procedure of hepatic radioembolization
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: Device Feasibility
  time frame: Immediately after surgery
  description: The feasibility of IXSI will be assessed by questionnaires filled in by interventional radiology personnel
  measure: Radioactivity distribution over time
  time frame: Immediately after surgery
  description: The radioactivity distribution in the liver segments will be measured over time to assess potential dynamic behavior
  measure: Radioactivity distribution in 3D
  time frame: Immediately after surgery
  description: The quality of IXSI scans will be assessed by measuring the radioactivity distribution in the liver segments in 3D
  arm group label: Hybrid imaging during the pre-treatment procedure of radioembolization
  arm group type: Experimental
  description: Hybrid imaging will be performed on patients undergoing the pre-treatment procedure of radioembolization
  intervention type: Device
  intervention name: IXSI
  description: Hybrid imaging with IXSI will be performed during the radioembolization pre-treatment procedure
  arm group label: Hybrid imaging during the pre-treatment procedure of radioembolization
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: UMC Utrecht
  investigator full name: Hugo de Jong
  investigator title: Principal Investigator
  mesh term: Liver Neoplasms