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/NCT06008522</url>
    </required_header>
    <id_info>
      <org_study_id>11258</org_study_id>
      <nct_id>NCT06008522</nct_id>
    </id_info>
    <brief_title>Safety and Feasibility of Immuno-OCT</brief_title>
    <acronym>DETOUR</acronym>
    <official_title>Determining the Safety and Feasibility of Optical Coherence Tomography and Near Infrared Fluorescence: a Prospective Pilot Intervention Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Medical Center Groningen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Medical Center Groningen</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>
        To improve detection of premalignant lesions in the gastrointestinal tract (the rectum and&#xD;
        the esophagus) there is a need for better endoscopic visualization and the ability for&#xD;
        targeted biopsies. The University Medical Center Groningen (UMCG) developed a fluorescent&#xD;
        tracer by labelling the VEGF-A-targeting humanized monoclonal antibody bevacizumab, currently&#xD;
        used in anti-cancer therapy, with the fluorescent dye bevacizumab-800CW (IRDye800CW). In&#xD;
        several phase I studies and phase II studies, either completed or currently running, in the&#xD;
        UMCG, the use of VEGF-A-guided near-infrared (NIR) fluorescence molecular endoscopy (FME) in&#xD;
        combination with high-definition white light endoscopy (HD-WLE) shows an improved detection&#xD;
        rate of early premalignant lesions. In this study the safety and feasibility of a next&#xD;
        generation imaging system will be tested. This system uses immune optical coherence&#xD;
        tomography (immuno-OCT) and near infrared fluorescence (NIRF) with the targeted tracer&#xD;
        (Bevacizumab-800CW) for improvement of the detection of dysplastic lesions in Barret's&#xD;
        esophagus (BE) and colorectal polyp detection. The system provides more depth information and&#xD;
        can eventually be used without the guidance of the regular endoscopy system.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Adverse Device-related Events (ADEs) and Serious Adverse Device-related Events (SADEs) using immuno-OCT</measure>
      <time_frame>during procedure</time_frame>
      <description>Any events related to the device.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Validation of the immuno-OCT system: FME</measure>
      <time_frame>During procedure</time_frame>
      <description>Validation of the immuno-OCT endoscopy results compared to fluorescence seen in FME imaging results.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Validation of OCT system: Ex vivo fluorescence imaging</measure>
      <time_frame>During procedure</time_frame>
      <description>Validation of the immuno-OCT endoscopy results compared to the correlation of ex vivo fluorescent signals to histopathological analysis results.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>validation of OCT system: ex vivo immuno-OCT imaging</measure>
      <time_frame>During procedure</time_frame>
      <description>Validation of the immuno-OCT endoscopy results compared to the correlation of in vivo and ex vivo immuno-OCT imaging to histopathological analysis results.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>validation of OCT system: immunohistochemistry</measure>
      <time_frame>Once, as soon as possible after procedure</time_frame>
      <description>Validation of the in vivo immune-OCT endoscopy results by comparing it to histopathological analysis results.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Colon Carcinoma</condition>
    <condition>Barrett Esophagus</condition>
    <condition>Gastrointestinal Dysplasia</condition>
    <arm_group>
      <arm_group_label>OCT with IV in colorectal polyps</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>OCT and FME imaging of Barret and colorectal lesions during endoscopy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bevacizumab-800CW</intervention_name>
      <description>Imaging of fluorescently labeled Bevacizumab-800CW using OCT.</description>
      <arm_group_label>OCT with IV in colorectal polyps</arm_group_label>
      <other_name>OCT imaging</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Indication for a therapeutic endoscopy procedure (EMR or ESD);&#xD;
  &#xD;
            -  Age ≥ 18;&#xD;
  &#xD;
            -  Written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients younger than 18 years old;&#xD;
  &#xD;
            -  Submucosal and invasive esophageal adenocarcinoma (EAC) or colorectal carcinoma (CRC);&#xD;
  &#xD;
            -  Radiation therapy for esophageal or colorectal cancer;&#xD;
  &#xD;
            -  History of infusion reactions to Bevacizumab or other monoclonal antibodies;&#xD;
  &#xD;
            -  Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer;&#xD;
  &#xD;
            -  Non-adjustable hypertension;&#xD;
  &#xD;
            -  Medical or psychiatric conditions that compromise the patient's ability to give&#xD;
               informed consent;&#xD;
  &#xD;
            -  Pregnancy or breastfeeding; a negative pregnancy test must be available for women of&#xD;
               childbearing potential.&#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>W.B. Nagengast, MD, PhD, PharmD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Medical Center Groningen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>W.B. Nagengast, MD, PhD, PharmD</last_name>
      <phone>+31503612620</phone>
      <email>w.b.nagengast@umcg.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Andrea Sterkenburg, MSc</last_name>
      <phone>+316 55257029</phone>
      <email>a.j.sterkenburg@umcg.nl</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
      <investigator_full_name>dr. W.B. Nagengast, MD</investigator_full_name>
      <investigator_title>Prof. dr. W.B. Nagengast</investigator_title>
    </responsible_party>
    <keyword>optical coherence tomography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Barrett Esophagus</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bevacizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06008522
  org study id: 11258
  nct id: NCT06008522
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To improve detection of premalignant lesions in the gastrointestinal tract (the rectum and
        the esophagus) there is a need for better endoscopic visualization and the ability for
        targeted biopsies. The University Medical Center Groningen (UMCG) developed a fluorescent
        tracer by labelling the VEGF-A-targeting humanized monoclonal antibody bevacizumab, currently
        used in anti-cancer therapy, with the fluorescent dye bevacizumab-800CW (IRDye800CW). In
        several phase I studies and phase II studies, either completed or currently running, in the
        UMCG, the use of VEGF-A-guided near-infrared (NIR) fluorescence molecular endoscopy (FME) in
        combination with high-definition white light endoscopy (HD-WLE) shows an improved detection
        rate of early premalignant lesions. In this study the safety and feasibility of a next
        generation imaging system will be tested. This system uses immune optical coherence
        tomography (immuno-OCT) and near infrared fluorescence (NIRF) with the targeted tracer
        (Bevacizumab-800CW) for improvement of the detection of dysplastic lesions in Barret's
        esophagus (BE) and colorectal polyp detection. The system provides more depth information and
        can eventually be used without the guidance of the regular endoscopy system.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Number of Adverse Device-related Events (ADEs) and Serious Adverse Device-related Events (SADEs) using immuno-OCT
  time frame: during procedure
  description: Any events related to the device.
  measure: Validation of the immuno-OCT system: FME
  time frame: During procedure
  description: Validation of the immuno-OCT endoscopy results compared to fluorescence seen in FME imaging results.
  measure: Validation of OCT system: Ex vivo fluorescence imaging
  time frame: During procedure
  description: Validation of the immuno-OCT endoscopy results compared to the correlation of ex vivo fluorescent signals to histopathological analysis results.
  measure: validation of OCT system: ex vivo immuno-OCT imaging
  time frame: During procedure
  description: Validation of the immuno-OCT endoscopy results compared to the correlation of in vivo and ex vivo immuno-OCT imaging to histopathological analysis results.
  measure: validation of OCT system: immunohistochemistry
  time frame: Once, as soon as possible after procedure
  description: Validation of the in vivo immune-OCT endoscopy results by comparing it to histopathological analysis results.
  arm group label: OCT with IV in colorectal polyps
  arm group type: Experimental
  description: OCT and FME imaging of Barret and colorectal lesions during endoscopy.
  intervention type: Drug
  intervention name: Bevacizumab-800CW
  description: Imaging of fluorescently labeled Bevacizumab-800CW using OCT.
  arm group label: OCT with IV in colorectal polyps
  other name: OCT imaging
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: W.B. Nagengast, MD, PhD, PharmD
  role: Principal Investigator
  affiliation: University Medical Center Groningen
  last name: W.B. Nagengast, MD, PhD, PharmD
  phone: +31503612620
  email: w.b.nagengast@umcg.nl
  last name: Andrea Sterkenburg, MSc
  phone: +316 55257029
  email: a.j.sterkenburg@umcg.nl
  responsible party type: Principal Investigator
  investigator affiliation: University Medical Center Groningen
  investigator full name: dr. W.B. Nagengast, MD
  investigator title: Prof. dr. W.B. Nagengast
  mesh term: Barrett Esophagus
  mesh term: Bevacizumab
  sharing ipd: No