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/NCT06034197</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-68096</org_study_id>
      <nct_id>NCT06034197</nct_id>
    </id_info>
    <brief_title>Fluorescent Probe VGT-309 to ID Cancerous Colorectal Lesions During Augmented Colonoscopy</brief_title>
    <official_title>Pilot Open Label Study to Determine the Safety and Efficacy of Fluorescent Probe, VGT-309, to Identify Cancerous Colorectal Lesions During White-Light and Fluorescence Augmented Colonoscopy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Stanford's Innovative Medicines Accelerator</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Stanford University</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to determine the safety and feasibility of VGT-309 for the&#xD;
        visualization of colorectal tumors in real-time using near-infrared (NIR) fluorescence&#xD;
        endoscopy. In addition, signatures of 50+ biomarkers will be evaluated in biopsies using&#xD;
        CODEX multi-plexing.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <phase>Early Phase 1</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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety Profile of VGT309</measure>
      <time_frame>18 days</time_frame>
      <description>Safety profile will be measured by assessing number of Grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably or possibly related.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of VGT-309</measure>
      <time_frame>18 days</time_frame>
      <description>Feasibility to visualize colorectal tumors using NIR-endoscopy will be measured by the tumor-to-background ratio (fluorescence intensity of tumor tissue divided by the fluorescence intensity of normal surrounding tissue) and the concordance between white-light endoscopy assessment, histopathological examination and NIR imaging assessment.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>VGT-309</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive an IV infusion of 0.32 mg/kg VGT-309 12 to 36 hours before a standard of care endoscopy procedure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VGT-309</intervention_name>
      <description>0.32mg/kg IV of VGT-309 given 12-36 hours before surgery</description>
      <arm_group_label>VGT-309</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Adult patients with histologically confirmed distal colorectal adenocarcinoma of&#xD;
               any stage.&#xD;
  &#xD;
               2. Be willing and able to sign the informed consent and comply with study procedures.&#xD;
  &#xD;
               3. Are scheduled to undergo a SOC colonoscopy for restaging following&#xD;
               radiochemotherapy or are scheduled to receive a SOC colonoscopy in the OR prior to&#xD;
               resection 4. Have acceptable kidney and liver functions at study entry as evidenced&#xD;
               by:&#xD;
  &#xD;
               a. ALT/AST &lt; 1.5 times the upper limit of normal, b. Creatinine clearance (according&#xD;
               to Cockcroft-Gault Equation) &gt; 50 mL/min c. Total bilirubin &lt; 1.5 times the upper&#xD;
               limit of normal 5. Have an ECOG score of 0-2. 6. Be at least 18 years of age. 7.&#xD;
               Female participants must be of non-childbearing potential, or, if of childbearing&#xD;
               potential be non-pregnant or lactating and agree to use highly effective contraception&#xD;
               from screening through 30 days after probe infusion 8. Male participants, if not&#xD;
               surgically sterilized, and if engaging in sexual intercourse with a female partner of&#xD;
               childbearing potential, must be willing to use highly effective contraception from&#xD;
               screening through 30 days post-dose and agree not to donate semen during this waiting&#xD;
               period.&#xD;
  &#xD;
               9. Highly effective contraception involves the use of a condom for the male, plus one&#xD;
               of the following for the female:&#xD;
  &#xD;
                 1. Oral, injectable, implantable, intravaginal, or transdermal hormonal&#xD;
                    contraceptives, or&#xD;
  &#xD;
                 2. Intrauterine device or intrauterine hormone-releasing system. NOTE: Participants&#xD;
                    who abstain from heterosexual intercourse as their usual and preferred lifestyle,&#xD;
                    will not be required to use contraception as described above. They are required&#xD;
                    to maintain abstinence from screening through Day 30, AND Participants in a same&#xD;
                    sex relationship, must use a barrier form of contraception (e.g., condom,&#xD;
                    diaphragm) to protect against the transfer of the study drug in any bodily&#xD;
                    fluids.&#xD;
  &#xD;
                    Exclusion Criteria:&#xD;
  &#xD;
            -  1. Pregnant or breastfeeding females 2. They have a known allergy or reaction to ICG,&#xD;
               other radiographic contrast agents, or any component of VGT-309.&#xD;
  &#xD;
               3. Have congenital long QT syndrome or QTcF &gt; 450ms (males) or &gt;470ms (females) by&#xD;
               history or at Screening ECG.&#xD;
  &#xD;
               4. They are prisoners, institutionalized individuals, or are unable to consent for&#xD;
               themselves.&#xD;
  &#xD;
               5. Have any other comorbidity or habit that the Investigator believes will interfere&#xD;
               with their ability to comply with and complete the study.&#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>Stephan Rogalla, M.D., PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joaquin Tabera</last_name>
      <phone>831-710-7387</phone>
      <email>jtabera7@stanford.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marissa N Dobry</last_name>
      <phone>313-320-2240</phone>
      <email>mdobry@stanford.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Stanford University</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94304</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joaquin Tabera</last_name>
        <email>jtabera7@stanford.edu</email>
      </contact>
      <investigator>
        <last_name>Erqi L Pollom, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Shai Friedland, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>George A Fisher, MD, PhD</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 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 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 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal 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/NCT06034197
  org study id: IRB-68096
  nct id: NCT06034197
  lead sponsor: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to determine the safety and feasibility of VGT-309 for the
        visualization of colorectal tumors in real-time using near-infrared (NIR) fluorescence
        endoscopy. In addition, signatures of 50+ biomarkers will be evaluated in biopsies using
        CODEX multi-plexing.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Safety Profile of VGT309
  time frame: 18 days
  description: Safety profile will be measured by assessing number of Grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably or possibly related.
  measure: Feasibility of VGT-309
  time frame: 18 days
  description: Feasibility to visualize colorectal tumors using NIR-endoscopy will be measured by the tumor-to-background ratio (fluorescence intensity of tumor tissue divided by the fluorescence intensity of normal surrounding tissue) and the concordance between white-light endoscopy assessment, histopathological examination and NIR imaging assessment.
  arm group label: VGT-309
  arm group type: Experimental
  description: Subjects will receive an IV infusion of 0.32 mg/kg VGT-309 12 to 36 hours before a standard of care endoscopy procedure.
  intervention type: Drug
  intervention name: VGT-309
  description: 0.32mg/kg IV of VGT-309 given 12-36 hours before surgery
  arm group label: VGT-309
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Stephan Rogalla, M.D., PhD
  role: Principal Investigator
  affiliation: Stanford University
  last name: Joaquin Tabera
  phone: 831-710-7387
  email: jtabera7@stanford.edu
  last name: Marissa N Dobry
  phone: 313-320-2240
  email: mdobry@stanford.edu
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms