<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/NCT03290534</url>
  </required_header>
  <id_info>
    <org_study_id>CT006</org_study_id>
    <nct_id>NCT03290534</nct_id>
  </id_info>
  <brief_title>Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®</brief_title>
  <official_title>Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CivaTech Oncology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CivaTech Oncology</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>
      This is a feasibility study to determine the usefulness of a brachytherapy device that&#xD;
      utilizes active components (palladium-103) of standard devices in a novel configuration,&#xD;
      which may benefit lung cancer patients by reducing the radiation dose to critical structures,&#xD;
      such as the heart wall, while giving a therapeutic dose to diseased tissue, such as at a&#xD;
      surgical margin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 13, 2019</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Local Control Rate at 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>The local control rate in the region irradiated by CivaSheet.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from regional or distant recurrence</measure>
    <time_frame>1 year</time_frame>
    <description>Control rate for recurrences outside the local area irradiated by CivaSheet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recurrence</measure>
    <time_frame>1 year</time_frame>
    <description>Time in months to any recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity graded on CTCAE 4.0 Scale</measure>
    <time_frame>1 year</time_frame>
    <description>pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Lung Cancer Stage I</condition>
  <condition>Lung Cancer Stage II</condition>
  <arm_group>
    <arm_group_label>CivaSheet Directional LDR Brachytherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FDA Cleared CivaSheet directional Pd-103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CivaSheet</intervention_name>
    <description>implanting CivaSheet for localized radiation dose delivery</description>
    <arm_group_label>CivaSheet Directional LDR Brachytherapy</arm_group_label>
    <other_name>brachytherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject signed inform consent&#xD;
&#xD;
          -  Suspected or proven non-small cell lung cancer (NSCLC) in the upper lobes of the left&#xD;
             or right lung&#xD;
&#xD;
          -  Pre-operative criteria&#xD;
&#xD;
          -  Lung nodule suspicious for NSCLC&#xD;
&#xD;
          -  Mass ≤ 7 cm in maximum diameter by CT scan of the chest and upper abdomen&#xD;
&#xD;
          -  Clinical stage I or Clinical stage II&#xD;
&#xD;
          -  Not pregnant or nursing&#xD;
&#xD;
          -  Negative pregnancy test in premenopausal women&#xD;
&#xD;
          -  Fertile patients must use effective contraception&#xD;
&#xD;
          -  More than 5 years since prior invasive malignancy unless non melanoma skin cancer or&#xD;
             in-situ cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Abe Wu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MSKCC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kristy Perez, PhD</last_name>
    <phone>9193145515</phone>
    <email>kperez@civatechoncology.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed El Zaeedi</last_name>
    </contact>
    <investigator>
      <last_name>Michael Zervos, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Benjamin Cooper, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</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>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>wedge resection</keyword>
  <keyword>sublobar resection</keyword>
  <keyword>brachytherapy</keyword>
  <keyword>CivaSheet</keyword>
  <keyword>Pd-103</keyword>
  <keyword>CivaTech Oncology</keyword>
  <keyword>lung cancer</keyword>
  <keyword>lung</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</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/NCT03290534
org study id: CT006
nct id: NCT03290534
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a feasibility study to determine the usefulness of a brachytherapy device that
      utilizes active components (palladium-103) of standard devices in a novel configuration,
      which may benefit lung cancer patients by reducing the radiation dose to critical structures,
      such as the heart wall, while giving a therapeutic dose to diseased tissue, such as at a
      surgical margin.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local Control Rate at 1 year
time frame: 1 year
description: The local control rate in the region irradiated by CivaSheet.
measure: Freedom from regional or distant recurrence
time frame: 1 year
description: Control rate for recurrences outside the local area irradiated by CivaSheet.
measure: Time to recurrence
time frame: 1 year
description: Time in months to any recurrence
measure: Toxicity graded on CTCAE 4.0 Scale
time frame: 1 year
description: pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc.
arm group label: CivaSheet Directional LDR Brachytherapy
arm group type: Experimental
description: FDA Cleared CivaSheet directional Pd-103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.
intervention type: Device
intervention name: CivaSheet
description: implanting CivaSheet for localized radiation dose delivery
arm group label: CivaSheet Directional LDR Brachytherapy
other name: brachytherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abe Wu, MD
role: Principal Investigator
affiliation: MSKCC
last name: Kristy Perez, PhD
phone: 9193145515
email: kperez@civatechoncology.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No