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/NCT06007261</url>
    </required_header>
    <id_info>
      <org_study_id>IMAGIO-VALIDIAG</org_study_id>
      <nct_id>NCT06007261</nct_id>
    </id_info>
    <brief_title>Validation of Rapid On-site Diagnostics in Early Stage Lung Cancer Sampling With a Higher Harmonic Generation Microscope</brief_title>
    <acronym>VALIDIAG</acronym>
    <official_title>Validation and Added Clinical Value of Rapid On-site Diagnostics in Early Stage Lung Cancer Sampling With a Higher Harmonic Generation Microscope</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Radboud University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Flash Pathology BV</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>VU University of Amsterdam</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>ETH Zurich</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Radboud University Medical Center</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>
        The aim of this study is to verify a new microscopic technique in diagnosing patients&#xD;
        suspected of lung cancer. Patients will undergo navigational bronchoscopy as a part of&#xD;
        standard of care. Biopsies taken during this procedure will be imaged for a few minutes with&#xD;
        a higher harmonic generation (HHG) microscope, after which the material is taken to the&#xD;
        pathology department for histopathology assessment, which is currently the golden standard&#xD;
        for diagnosis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">April 2027</completion_date>
    <primary_completion_date type="Anticipated">April 2027</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>20 Years</target_duration>
    <primary_outcome>
      <measure>The ability to obtain a diagnosis from HHG microscopy images as judged by the pathologist</measure>
      <time_frame>48 months</time_frame>
      <description>Accuracy of HHG microscopy obtained and assessed images for diagnosing pathology as compared against golden standard routine clinical follow up pathology tissue evaluation techniques (H&amp;E staining and if used, additional stains), as judged by the pathologist.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The ability to obtain a diagnosis from HHG microscopy images as autonomously assessed by a developed AI algorithm.</measure>
      <time_frame>48 months</time_frame>
      <description>Accuracy of HHG microscopy image based AI algorithm for autonomous diagnosis of pathology as compared against diagnosis of conventional golden standard routine clinical follow up pathology tissue evaluation techniques (H&amp;E staining and if used, additional stains).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The ability to obtain a diagnosis from HHG microscopy images as judged during the procedure (rapid on-site) by the cyto-technician or pathologist.</measure>
      <time_frame>48 months</time_frame>
      <description>Accuracy of Rapid-On site Assessment (ROSE) of HHG microscopy obtained images when compared against golden standard routinely used ROSE technique in navigation bronchoscopy&#xD;
  Accuracy of Rapid-On site Assessment (ROSE) of HHG microscopy obtained images when compared against golden standard routinely used frozen wedge assessment in cardiothoracic surgery.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Lung Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will consist of patients with a pulmonary lesion(s) with an indication&#xD;
          for surgical resection according to guideline recommended care, multi-discplinary tumor&#xD;
          board decision making and patient preferences. Median age will be approximately 65 years.&#xD;
          Sex distribution will be approximately 50-60% male, 40-50% female based on prior studies at&#xD;
          the Radboudumc.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA physical status 1-3.&#xD;
  &#xD;
            -  Age 18 years or older.&#xD;
  &#xD;
            -  A pulmonary lesion with an indication for diagnostic or therapeutic evaluation&#xD;
               following current clinical guidelines and/or as decided by multi-disciplinary team&#xD;
               consultation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Bleeding disorders.&#xD;
  &#xD;
            -  Less than 18 years old.&#xD;
  &#xD;
            -  Inability to consent.&#xD;
  &#xD;
            -  Unfit for navigation bronchoscopy and/or unfit for surgical resection as per guideline&#xD;
               recommended care and multi-disciplinary tumor board decision making.&#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>Erik HF van der Heijden, Prof. dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Radboud University Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Roel LJ Verhoeven, PhD</last_name>
      <phone>0031627495531</phone>
      <email>roel.lj.verhoeven@radboudumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Judith JM Leermakers-Ceelen, PhD</last_name>
      <phone>0031631117495</phone>
      <email>Judith.Leermakers-Ceelen@radboudumc.nl</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Navigation Bronchoscopy</keyword>
    <keyword>Higher harmonic generation microscopy</keyword>
    <keyword>Artificial intelligence</keyword>
    <keyword>Diagnostics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung 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/NCT06007261
  org study id: IMAGIO-VALIDIAG
  nct id: NCT06007261
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to verify a new microscopic technique in diagnosing patients
        suspected of lung cancer. Patients will undergo navigational bronchoscopy as a part of
        standard of care. Biopsies taken during this procedure will be imaged for a few minutes with
        a higher harmonic generation (HHG) microscope, after which the material is taken to the
        pathology department for histopathology assessment, which is currently the golden standard
        for diagnosis.
  observational model: Case-Only
  time perspective: Prospective
  measure: The ability to obtain a diagnosis from HHG microscopy images as judged by the pathologist
  time frame: 48 months
  description: Accuracy of HHG microscopy obtained and assessed images for diagnosing pathology as compared against golden standard routine clinical follow up pathology tissue evaluation techniques (H&E staining and if used, additional stains), as judged by the pathologist.
  measure: The ability to obtain a diagnosis from HHG microscopy images as autonomously assessed by a developed AI algorithm.
  time frame: 48 months
  description: Accuracy of HHG microscopy image based AI algorithm for autonomous diagnosis of pathology as compared against diagnosis of conventional golden standard routine clinical follow up pathology tissue evaluation techniques (H&E staining and if used, additional stains).
  measure: The ability to obtain a diagnosis from HHG microscopy images as judged during the procedure (rapid on-site) by the cyto-technician or pathologist.
  time frame: 48 months
  description: Accuracy of Rapid-On site Assessment (ROSE) of HHG microscopy obtained images when compared against golden standard routinely used ROSE technique in navigation bronchoscopy
  Accuracy of Rapid-On site Assessment (ROSE) of HHG microscopy obtained images when compared against golden standard routinely used frozen wedge assessment in cardiothoracic surgery.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Erik HF van der Heijden, Prof. dr.
  role: Principal Investigator
  affiliation: Radboud University Medical Center
  last name: Roel LJ Verhoeven, PhD
  phone: 0031627495531
  email: roel.lj.verhoeven@radboudumc.nl
  last name: Judith JM Leermakers-Ceelen, PhD
  phone: 0031631117495
  email: Judith.Leermakers-Ceelen@radboudumc.nl
  responsible party type: Sponsor
  mesh term: Lung Neoplasms