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/NCT06026943</url>
    </required_header>
    <id_info>
      <org_study_id>CTP-PANC-03</org_study_id>
      <nct_id>NCT06026943</nct_id>
    </id_info>
    <brief_title>Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer</brief_title>
    <official_title>A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Advanced Pancreatic Cancer</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>
      <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 for advanced pancreatic cancer&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, interventional, single-center, open label, single arm study. The study&#xD;
        is designed to evaluate the feasibility and Safety of Intratumoral Diffusing Alpha Radiation&#xD;
        Emitters for the Treatment of Locally Advanced Pancreatic Cancer&#xD;
  &#xD;
        The study will be comprised of a screening period, DaRT insertion visit, 3 months follow up&#xD;
        per subject and 2 years for accrual and trial completion. The total duration of the study&#xD;
        will be 24 months from the DaRT insertion procedure.&#xD;
  &#xD;
        15 patients with a safety interim analysis after the 5 first patients . patients with&#xD;
        advanced pancreatic cancer will be recruited by the investigational site.&#xD;
  &#xD;
        Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening&#xD;
        period) will be invited to the site for the procedure of DaRT seeds insertion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">January 2028</completion_date>
    <primary_completion_date type="Anticipated">January 2026</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>Feasibility- DaRT seed placement</measure>
      <time_frame>Immediately following the insertion procedure</time_frame>
      <description>Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Safety- Adverse events, Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria</measure>
      <time_frame>from DaRT-insertion up to 48 hours</time_frame>
      <description>Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To evaluate the Efficacy of the Alpha DaRT seeds for locally advanced pancreatic cancer</measure>
      <time_frame>1 months and 3 months</time_frame>
      <description>Local control evaluation according to RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the Efficacy of the Alpha DaRT seeds by measuring the CA-19-9 markers levels</measure>
      <time_frame>1 months and 3 months</time_frame>
      <description>Change in CA 19-9 levels</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy - to evaluate what is the percent of the Tumor Coverage by the Alpha DaRT seeds</measure>
      <time_frame>immediately following the insertion procedure]</time_frame>
      <description>Tumor Coverage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy- Alpha DaRT seeds</measure>
      <time_frame>from DaRT-insertion up to initiation of a possible postablation therapy or up to a maximum three months</time_frame>
      <description>Overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Exploratory Objective -to evaluate the changes in the immune markers by Blood samples for immune response</measure>
      <time_frame>1 month</time_frame>
      <description>Changes in immune markers following treatment ,These biomarkers include:&#xD;
  CD3&#xD;
  CD4&#xD;
  CD8&#xD;
  CD69&#xD;
  CD137</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Pancreatic Cancer</condition>
    <condition>Unresectable Pancreatic Cancer</condition>
    <condition>Pancreatic Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>DaRT Seeds</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>DaRT seeds insertion</intervention_name>
      <description>An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms</description>
      <arm_group_label>DaRT Seeds</arm_group_label>
      <other_name>Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically and/or cytologically proven NCCN locally advanced PC&#xD;
  &#xD;
            -  Patients must have i) received at least one line of chemotherapy (any kind) OR ii) are&#xD;
               medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as&#xD;
               resectable with radical surgery, or the patient does not wish to go through surgery.&#xD;
  &#xD;
            -  DaRT indication validated by a multidisciplinary team.&#xD;
  &#xD;
            -  Measurable lesion per RECIST (version 1.1) criteria&#xD;
  &#xD;
            -  TC at Verona's center (not been over a month)&#xD;
  &#xD;
            -  Lesion size ≤ 5 cm in the longest diameter&#xD;
  &#xD;
            -  Age ≥18 years old&#xD;
  &#xD;
            -  ECOG Performance Status Scale ≤ 2&#xD;
  &#xD;
            -  Life expectancy is more than 6 months&#xD;
  &#xD;
            -  WBC ≥ 3500/μl, granulocyte ≥ 1500/μl&#xD;
  &#xD;
            -  Platelet count ≥60,000/μl&#xD;
  &#xD;
            -  Calculated or measured creatinine clearance ≥ 30cc/min. Calculated or measured&#xD;
               creatinine clearance can be ≥ 40cc/min given stability of creatinine levels over the&#xD;
               past three weeks (at least 1 test per week).&#xD;
  &#xD;
            -  AST and ALT ≤ 2.5 X upper limit of normal (ULN)&#xD;
  &#xD;
            -  INR &lt; 1.4 for patients not on Warfarin&#xD;
  &#xD;
            -  Subjects are willing and able to sign an informed consent form&#xD;
  &#xD;
            -  Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test&#xD;
               before the Ra-224 implantation and are required to use an acceptable contraceptive&#xD;
               method to prevent pregnancy for 3 months after brachytherapy.&#xD;
  &#xD;
            -  Patients must agree to use adequate contraception (vasectomy or barrier method of&#xD;
               birth control) prior to study entry, for the duration of study participation and for 3&#xD;
               months after discontinuing therapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Concomitant chemotherapy or immunotherapy within the past 4 weeks&#xD;
  &#xD;
            -  Prior radiation therapy to the pancreas&#xD;
  &#xD;
            -  CA 19-9 &gt; 1000 Units/ml&#xD;
  &#xD;
            -  Fit for surgical exploration unless the patient refuses surgery&#xD;
  &#xD;
            -  Known hypersensitivity to any of the components of the treatment.&#xD;
  &#xD;
            -  Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief&#xD;
               use of systemic corticosteroids.&#xD;
  &#xD;
            -  Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart&#xD;
               Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy,&#xD;
               uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial&#xD;
               infarction in the last 12 months.&#xD;
  &#xD;
            -  Patients with uncontrolled intercurrent illnesses including, but not limited to an&#xD;
               active infection requiring systemic therapy (not including cholangitis) or a known&#xD;
               psychiatric or substance abuse disorder(s) that would interfere with cooperation with&#xD;
               the requirements of the trial or interfere with the study endpoints.&#xD;
  &#xD;
            -  Has a known additional malignancy that is progressing or requires active treatment.&#xD;
               Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the&#xD;
               skin that has undergone potentially curative therapy or in situ cervical cancer.&#xD;
  &#xD;
            -  Patient requires treatment not specified in this protocol which may conflict with the&#xD;
               endpoints of this study including evaluation of response or toxicity of DaRT.&#xD;
  &#xD;
            -  Patients do not agree to use adequate contraception (vasectomy or barrier method of&#xD;
               birth control) prior to study entry, for the duration of study participation and for 3&#xD;
               months after discontinuing therapy.&#xD;
  &#xD;
            -  Volunteers participating in another interventional study in the past 30 days which&#xD;
               might conflict with the endpoints of this study or the evaluation of response or&#xD;
               toxicity of DaRT.&#xD;
  &#xD;
            -  High probability of protocol non-compliance (in opinion of investigator).&#xD;
  &#xD;
            -  Breastfeeding women or women of childbearing potential unwilling or unable to use an&#xD;
               acceptable contraceptive method to prevent pregnancy for 3 months after RT.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>120 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Salvatore Paiella, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Pancreas Institute - Integrated University Hospital of Verona</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Liron Dimnik</last_name>
      <phone>+972-2-3737-7000</phone>
      <email>LironD@alphatau.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>pancreatic cancer</keyword>
    <keyword>Unresectable Pancreatic Cancer</keyword>
    <keyword>Pancreatic Adenocarcinoma</keyword>
    <keyword>Alpha radiation</keyword>
    <keyword>Pancreas Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenocarcinoma</mesh_term>
      <mesh_term>Pancreatic 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/NCT06026943
  org study id: CTP-PANC-03
  nct id: NCT06026943
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A unique approach for cancer treatment employing intratumoral diffusing alpha radiation
        emitter device for advanced pancreatic cancer
  This is a prospective, interventional, single-center, open label, single arm study. The study
        is designed to evaluate the feasibility and Safety of Intratumoral Diffusing Alpha Radiation
        Emitters for the Treatment of Locally Advanced Pancreatic Cancer
  
        The study will be comprised of a screening period, DaRT insertion visit, 3 months follow up
        per subject and 2 years for accrual and trial completion. The total duration of the study
        will be 24 months from the DaRT insertion procedure.
  
        15 patients with a safety interim analysis after the 5 first patients . patients with
        advanced pancreatic cancer will be recruited by the investigational site.
  
        Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening
        period) will be invited to the site for the procedure of DaRT seeds insertion.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Feasibility- DaRT seed placement
  time frame: Immediately following the insertion procedure
  description: Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging
  measure: Safety- Adverse events, Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
  time frame: from DaRT-insertion up to 48 hours
  description: Safety will be determined according to the overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
  measure: To evaluate the Efficacy of the Alpha DaRT seeds for locally advanced pancreatic cancer
  time frame: 1 months and 3 months
  description: Local control evaluation according to RECIST v1.1
  measure: To evaluate the Efficacy of the Alpha DaRT seeds by measuring the CA-19-9 markers levels
  time frame: 1 months and 3 months
  description: Change in CA 19-9 levels
  measure: Efficacy - to evaluate what is the percent of the Tumor Coverage by the Alpha DaRT seeds
  time frame: immediately following the insertion procedure]
  description: Tumor Coverage
  measure: Efficacy- Alpha DaRT seeds
  time frame: from DaRT-insertion up to initiation of a possible postablation therapy or up to a maximum three months
  description: Overall incidence of device-related SAE's graded according to CTCAE v5.0 criteria
  measure: Exploratory Objective -to evaluate the changes in the immune markers by Blood samples for immune response
  time frame: 1 month
  description: Changes in immune markers following treatment ,These biomarkers include:
  CD3
  CD4
  CD8
  CD69
  CD137
  arm group label: DaRT Seeds
  arm group type: Experimental
  description: Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
  intervention type: Device
  intervention name: DaRT seeds insertion
  description: An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms
  arm group label: DaRT Seeds
  other name: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 120 Years
  healthy volunteers: No
  last name: Salvatore Paiella, MD
  role: Principal Investigator
  affiliation: Pancreas Institute - Integrated University Hospital of Verona
  last name: Liron Dimnik
  phone: +972-2-3737-7000
  email: LironD@alphatau.com
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  mesh term: Pancreatic Neoplasms