<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/NCT04459065</url>
  </required_header>
  <id_info>
    <org_study_id>CBIRD.20190430.Nimo800CW</org_study_id>
    <nct_id>NCT04459065</nct_id>
  </id_info>
  <brief_title>Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery</brief_title>
  <official_title>Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Western Economic Diversification Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Saskatchewan</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>
      The purpose of this study is to determine the safety, optimal dose and imaging time of the&#xD;
      investigational product, IRDye800CW-nimotuzumab for use as a near infrared imaging probe for&#xD;
      image-guided surgery during lung cancer resection. IRDye800CW-nimotuzumab targets cancer&#xD;
      cells over-expressing EGFR, allowing tumors to be visualized and may help surgeons better&#xD;
      identify cancer during surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Single center, open-label, phase I/II image-guided surgery study to assess the image quality of IRDye800CW-nimotuzumab during surgery</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.</measure>
    <time_frame>up to 14 days</time_frame>
    <description>To identify the dose with the highest tumor fluorescence and TBR.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.</measure>
    <time_frame>up to 14 days</time_frame>
    <description>To identify the imaging time with the highest tumor fluorescence and TBR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine primary tumor margins.</measure>
    <time_frame>up to 14 days</time_frame>
    <description>Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify EGFR positive lymph nodes.</measure>
    <time_frame>up to 14 days</time_frame>
    <description>Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of IRDye800CW-nimotuzumab</measure>
    <time_frame>up to 14 days</time_frame>
    <description>a. Safety will be determined by recording the number of grade 2 or higher adverse events determined to be clinically significant, which are definitely, probably, or possibly related to IRDye800CW-nimotuzumab within 30 days of administration.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Low dose intermediate time</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an i.v. infusion of 50 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose intermediate time</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an i.v. infusion of 100 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Optimal dose early time</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on results from cohorts 1 and 2). Participants will undergo lung cancer resection surgery 1-3 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Optimal dose late time</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on cohorts 1 and 2). Participants will undergo lung cancer resection surgery 7+ days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IRDye800CW-nimotuzumab</intervention_name>
    <description>50 mg of IRDye800CW-nimotuzumab will be infused intravenously over a period of 30 minutes. Lung cancer resection surgery will be done at different time points post infusion</description>
    <arm_group_label>High dose intermediate time</arm_group_label>
    <arm_group_label>Low dose intermediate time</arm_group_label>
    <arm_group_label>Optimal dose early time</arm_group_label>
    <arm_group_label>Optimal dose late time</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgically resectable Stage I and II non-small cell lung cancer&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 80 years old&#xD;
&#xD;
          -  Adequate cardiopulmonary reserve to undergo lung resection as determined by operating&#xD;
             surgeon&#xD;
&#xD;
          -  No prior history of malignancy&#xD;
&#xD;
          -  No neoadjuvant therapy&#xD;
&#xD;
          -  Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group&#xD;
             (ECOG)/Zubrod level 0-2&#xD;
&#xD;
          -  Hemoglobin (hgb) ≥ 90 g/L&#xD;
&#xD;
          -  White blood cell count (WBC) &gt; 3 x 109/L&#xD;
&#xD;
          -  Platelet count (plt) ≥ 100 x 109/L&#xD;
&#xD;
          -  Serum creatinine ≤ 1.5 times upper reference range&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received anti-EGFR antibody therapy (cetuximab, panitumumab, necitumumab) within 60&#xD;
             days prior to trial drug&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Known history of hypersensitivities or allergic reactions to antibodies or NSO derived&#xD;
             products&#xD;
&#xD;
          -  Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive&#xD;
             heart failure (CHF); significant liver disease; or unstable angina within 6 months&#xD;
             prior to enrollment&#xD;
&#xD;
          -  Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide,&#xD;
             amiodarone, sotalol) antiarrhythmic agents&#xD;
&#xD;
          -  Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis&#xD;
&#xD;
          -  Any condition which in the investigator's opinion deems the participant an unsuitable&#xD;
             candidate to receive study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ron Geyer, PhD</last_name>
    <phone>306-966-12040</phone>
    <email>ron.geyer@usask.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7M 0Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ronald Geyer, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Humphrey Fonge, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kris Barreto, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wendy Bernhard, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
    <investigator_full_name>Steven Bharadwaj</investigator_full_name>
    <investigator_title>Thoracic surgeon</investigator_title>
  </responsible_party>
  <keyword>IRDye800CW</keyword>
  <keyword>Nimotuzumab</keyword>
  <keyword>Lung cancer</keyword>
  <keyword>EGFR</keyword>
  <keyword>Near infrared</keyword>
  <keyword>Image guided surgery</keyword>
  <keyword>Optical imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nimotuzumab</mesh_term>
  </intervention_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/NCT04459065
org study id: CBIRD.20190430.Nimo800CW
nct id: NCT04459065
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the safety, optimal dose and imaging time of the
      investigational product, IRDye800CW-nimotuzumab for use as a near infrared imaging probe for
      image-guided surgery during lung cancer resection. IRDye800CW-nimotuzumab targets cancer
      cells over-expressing EGFR, allowing tumors to be visualized and may help surgeons better
      identify cancer during surgery.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Single center, open-label, phase I/II image-guided surgery study to assess the image quality of IRDye800CW-nimotuzumab during surgery
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
time frame: up to 14 days
description: To identify the dose with the highest tumor fluorescence and TBR.
measure: Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.
time frame: up to 14 days
description: To identify the imaging time with the highest tumor fluorescence and TBR.
measure: Determine primary tumor margins.
time frame: up to 14 days
description: Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.
measure: Identify EGFR positive lymph nodes.
time frame: up to 14 days
description: Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.
measure: Safety of IRDye800CW-nimotuzumab
time frame: up to 14 days
description: a. Safety will be determined by recording the number of grade 2 or higher adverse events determined to be clinically significant, which are definitely, probably, or possibly related to IRDye800CW-nimotuzumab within 30 days of administration.
arm group label: Low dose intermediate time
arm group type: Experimental
description: Participants will receive an i.v. infusion of 50 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration
arm group label: High dose intermediate time
arm group type: Experimental
description: Participants will receive an i.v. infusion of 100 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration
arm group label: Optimal dose early time
arm group type: Experimental
description: Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on results from cohorts 1 and 2). Participants will undergo lung cancer resection surgery 1-3 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration
arm group label: Optimal dose late time
arm group type: Experimental
description: Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on cohorts 1 and 2). Participants will undergo lung cancer resection surgery 7+ days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration
intervention type: Drug
intervention name: IRDye800CW-nimotuzumab
description: 50 mg of IRDye800CW-nimotuzumab will be infused intravenously over a period of 30 minutes. Lung cancer resection surgery will be done at different time points post infusion
arm group label: High dose intermediate time
arm group label: Low dose intermediate time
arm group label: Optimal dose early time
arm group label: Optimal dose late time
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ron Geyer, PhD
phone: 306-966-12040
email: ron.geyer@usask.ca
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Saskatchewan
investigator full name: Steven Bharadwaj
investigator title: Thoracic surgeon
mesh term: Lung Neoplasms
mesh term: Nimotuzumab
sharing ipd: No