<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/NCT03779009</url>
  </required_header>
  <id_info>
    <org_study_id>EC/2017/1356</org_study_id>
    <nct_id>NCT03779009</nct_id>
  </id_info>
  <brief_title>Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.</brief_title>
  <acronym>MINIMAL</acronym>
  <official_title>Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kom Op Tegen Kanker</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Ghent</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 project investigates the feasibility of laparoscopic fluorescent imaging for the&#xD;
      intraoperative detection of the sentinel lymph node (SLN) in colon cancer patients. In&#xD;
      addition, the topology of immunological and microenvironmental changes in normal and invaded&#xD;
      lymph nodes (LN's) will be correlated to the LN location (anatomical mapping).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's)</measure>
    <time_frame>up to 1 month after surgery</time_frame>
    <description>All LN in the resection specimen will be collected, mapped, and labeled. The SLN is defined as fluorescent hotspot that appears after injection of the tracer. Standard H&amp;E staining will be performed on LN sections and all mapped LN (including the SLN) will be analyzed for their tumor status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunological markers</measure>
    <time_frame>up to 12 months after surgery</time_frame>
    <description>Single cell suspensions will be prepared from all LN (including the SLNs) and the primary tumor. Cell suspensions will be analyzed for cytotoxic CD8+ CD45RO+T cells, CD4+ T helper cells, dendritic cell subsets (DC), natural killer (NK) cells, tumor-associated macrophages (TAM), and myeloid-derived suppressor cells (MDSCs) by multicolor fluorescence-activated cell sorting (FACS)-based immuno-panels. FACS is technique to detect and measure physical and chemical characteristics of a population of cells and provides quantifiable data.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Sentinel Lymph Node</condition>
  <arm_group>
    <arm_group_label>Tracer injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)</intervention_name>
    <description>Under laparoscopic control, 2.0 ml of ICG-nanocoll will be injected into the subserosa at four quadrants around the tumor. Directly after injection, near infrared (NIR) fluorescence images (Olympus, Tokyo, Japan) will be acquired. SLNs will be identified and marked.</description>
    <arm_group_label>Tracer injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tumor type: proven adenocarcinoma of the colon&#xD;
&#xD;
          -  Extent of disease (AJCC 7th edition): clinically node negative (stage II)&#xD;
             non-metastatic colon cancer&#xD;
&#xD;
          -  Locally resectable disease&#xD;
&#xD;
          -  Adequate mental faculty, allowing to understand the proposed treatment protocol and&#xD;
             provide informed consent&#xD;
&#xD;
          -  Laboratory data&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m2&#xD;
&#xD;
               -  Serum total bilirubin ≤ 1.5 mg/dl, except for known Gilbert's disease&#xD;
&#xD;
               -  Platelet count &gt; 100,000/µl&#xD;
&#xD;
               -  Hemoglobin &gt; 9g/dl&#xD;
&#xD;
               -  Neutrophil granulocytes &gt; 1,500/ml&#xD;
&#xD;
               -  International Normalized Ratio (INR) ≤ 2&#xD;
&#xD;
          -  Absence of alcohol and/or drug abuse&#xD;
&#xD;
          -  No inclusion in other clinical trials interfering with the study protocol&#xD;
&#xD;
          -  No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy&#xD;
&#xD;
          -  Absence of any severe organ insufficiency&#xD;
&#xD;
          -  No pregnancy or breast feeding&#xD;
&#xD;
          -  Adequate contraception in fertile patients&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Node positive and/or metastatic disease&#xD;
&#xD;
          -  Locally unresectable disease&#xD;
&#xD;
          -  Medically unfit patients (Karnofsky index &lt; 70%)&#xD;
&#xD;
          -  Allergies to any of the procedural substances (allergy to iodides, hypersensitivity to&#xD;
             products containing human albumin)&#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_contact>
    <last_name>Wim Ceelen</last_name>
    <phone>+32(0)93326251</phone>
    <email>wim.ceelen@ugent.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sarah Cosyns</last_name>
    <phone>+32(0)93321562</phone>
    <email>sarah.cosyns@ugent.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wim Ceelen</last_name>
      <phone>+32(0)93326251</phone>
      <email>wim.ceelen@ugent.be</email>
    </contact>
    <investigator>
      <last_name>Sarah Cosyns</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Ghent</investigator_affiliation>
    <investigator_full_name>GIHeelkunde</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic 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/NCT03779009
org study id: EC/2017/1356
nct id: NCT03779009
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The project investigates the feasibility of laparoscopic fluorescent imaging for the
      intraoperative detection of the sentinel lymph node (SLN) in colon cancer patients. In
      addition, the topology of immunological and microenvironmental changes in normal and invaded
      lymph nodes (LN's) will be correlated to the LN location (anatomical mapping).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's)
time frame: up to 1 month after surgery
description: All LN in the resection specimen will be collected, mapped, and labeled. The SLN is defined as fluorescent hotspot that appears after injection of the tracer. Standard H&E staining will be performed on LN sections and all mapped LN (including the SLN) will be analyzed for their tumor status.
measure: Immunological markers
time frame: up to 12 months after surgery
description: Single cell suspensions will be prepared from all LN (including the SLNs) and the primary tumor. Cell suspensions will be analyzed for cytotoxic CD8+ CD45RO+T cells, CD4+ T helper cells, dendritic cell subsets (DC), natural killer (NK) cells, tumor-associated macrophages (TAM), and myeloid-derived suppressor cells (MDSCs) by multicolor fluorescence-activated cell sorting (FACS)-based immuno-panels. FACS is technique to detect and measure physical and chemical characteristics of a population of cells and provides quantifiable data.
arm group label: Tracer injection
arm group type: Experimental
intervention type: Other
intervention name: ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)
description: Under laparoscopic control, 2.0 ml of ICG-nanocoll will be injected into the subserosa at four quadrants around the tumor. Directly after injection, near infrared (NIR) fluorescence images (Olympus, Tokyo, Japan) will be acquired. SLNs will be identified and marked.
arm group label: Tracer injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wim Ceelen
phone: +32(0)93326251
email: wim.ceelen@ugent.be
last name: Sarah Cosyns
phone: +32(0)93321562
email: sarah.cosyns@ugent.be
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Ghent
investigator full name: GIHeelkunde
investigator title: Principal investigator
mesh term: Colonic Neoplasms
sharing ipd: No