<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/NCT03015883</url>
  </required_header>
  <id_info>
    <org_study_id>CTP-SCC-00</org_study_id>
    <nct_id>NCT03015883</nct_id>
  </id_info>
  <brief_title>Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma</brief_title>
  <acronym>DaRT</acronym>
  <official_title>A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma (First in Man)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alpha Tau Medical LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alpha Tau Medical LTD.</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>
      A unique approach for cancer treatment employing intratumoral diffusing alpha radiation&#xD;
      emitter device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a prospective, first in man, controlled study, assessing the safety and efficacy&#xD;
      of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds&#xD;
      inserted into the tumor.&#xD;
&#xD;
      This approach combines the advantages of local intratumoral irradiation of the tumor, as used&#xD;
      in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that&#xD;
      will be introduced in quantities considerably lower than radiation therapy already used in&#xD;
      patients.&#xD;
&#xD;
      Lesions with histopathological diagnosis of squamous cell carcinoma will be studied.&#xD;
&#xD;
      Reduction in tumor size 30 days after DaRT insertion will be assessed.&#xD;
&#xD;
      Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Actual">June 25, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>30-45 days post seed insertion</time_frame>
    <description>The incidence, severity and frequency of all Adverse Events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction in Tumor size</measure>
    <time_frame>30-45 days post seed insertion</time_frame>
    <description>The reduction in tumor size 30-45 days after DaRT insertion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of NecroticTissue</measure>
    <time_frame>30-45 days post seed insertion</time_frame>
    <description>Percent of necrotic tissue in the tumor 30 days after DaRT insertion</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Diffusing Alpha Radiation Emitters Therapy (DaRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Diffusing Alpha Radiation Emitters Therapy (DaRT)</intervention_name>
    <description>An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.</description>
    <arm_group_label>Diffusing Alpha Radiation Emitters Therapy (DaRT)</arm_group_label>
    <other_name>DaRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histopathological confirmation of squamous cell carcinoma.&#xD;
&#xD;
          2. Tumor size ≤ 5 centimeters in the longest diameter.&#xD;
&#xD;
          3. Age over 18.&#xD;
&#xD;
          4. Women of childbearing potential will have evidence of negative pregnancy test.&#xD;
&#xD;
          5. Life expectancy of more than 6 months.&#xD;
&#xD;
          6. Performance status 2 (ECOG scale) or less.&#xD;
&#xD;
          7. Signed informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Tumor maximal diameter &gt; 5 centimeters.&#xD;
&#xD;
          2. Tumor of Keratoacanthoma histology.&#xD;
&#xD;
          3. Performance status ≥ 3 (ECOG scale).&#xD;
&#xD;
          4. Patients with moribund diseases, autoimmune diseases or vasculitis.&#xD;
&#xD;
          5. Patients under immunosuppressive and/or corticosteroid treatment.&#xD;
&#xD;
          6. Volunteers that participated in other studies in the past 30 days.&#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>Noga Kurman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Davidof Cancer Institution at the Rabin Medical Center Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Davidof Cancer Institution at the Rabin Medical Center Israel</name>
      <address>
        <city>Petah Tiqva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Squamous Cell Carcinoma</keyword>
  <keyword>Alpha emitting radiation</keyword>
  <keyword>Skin Cancer</keyword>
  <keyword>Carcinoma, Squamous</keyword>
  <keyword>HNSCC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</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/NCT03015883
org study id: CTP-SCC-00
nct id: NCT03015883
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation
      emitter device.
This will be a prospective, first in man, controlled study, assessing the safety and efficacy
      of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds
      inserted into the tumor.

      This approach combines the advantages of local intratumoral irradiation of the tumor, as used
      in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that
      will be introduced in quantities considerably lower than radiation therapy already used in
      patients.

      Lesions with histopathological diagnosis of squamous cell carcinoma will be studied.

      Reduction in tumor size 30 days after DaRT insertion will be assessed.

      Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events
time frame: 30-45 days post seed insertion
description: The incidence, severity and frequency of all Adverse Events
measure: Reduction in Tumor size
time frame: 30-45 days post seed insertion
description: The reduction in tumor size 30-45 days after DaRT insertion
measure: Percent of NecroticTissue
time frame: 30-45 days post seed insertion
description: Percent of necrotic tissue in the tumor 30 days after DaRT insertion
arm group label: Diffusing Alpha Radiation Emitters Therapy (DaRT)
arm group type: Experimental
description: Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices
intervention type: Radiation
intervention name: Diffusing Alpha Radiation Emitters Therapy (DaRT)
description: An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
arm group label: Diffusing Alpha Radiation Emitters Therapy (DaRT)
other name: DaRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Noga Kurman, MD
role: Principal Investigator
affiliation: Davidof Cancer Institution at the Rabin Medical Center Israel
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
sharing ipd: No