<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/NCT03290183</url>
  </required_header>
  <id_info>
    <org_study_id>NL60800.018.17</org_study_id>
    <nct_id>NCT03290183</nct_id>
  </id_info>
  <brief_title>Confocal Laser Endomicroscopy in Pleural Malignancies</brief_title>
  <official_title>Confocal Laser Endomicroscopy in Pleural Malignancies: A Comparison With Pathology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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>
      To date, the different biopsy methods, such as CT-guided pleural biopsy, mediastinal biopsy,&#xD;
      endosonography and thoracoscopy have their limitations in diagnosing pleural malignancies,&#xD;
      such as mesothelioma. Sampling errors frequently occur resulting in the common histological&#xD;
      finding of 'non-specific pleuritic/fibrosis', which presents a great uncertainty for&#xD;
      clinicians and patients. Confocal laser endomicroscopy (CLE) provides real-time imaging on a&#xD;
      cellular level, however data of CLE in pleural malignancies are lacking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Novel optical imaging techniques such as confocal laser endomicroscopy (CLE) have emerged in&#xD;
      recent years as techniques that actually enable in vivo real-time microscopic analysis of&#xD;
      malignancies of the GI-tract and lung cancer. Through recent advances the probe became small&#xD;
      enough to fit through a biopsy needle and can be used during CT-guided and endosonographic&#xD;
      guided biopsies (EUS-FNA). Patients with intra-thoracic malignancies often require invasive&#xD;
      procedures such as bronchoscopy, thoracoscopy, mediastinoscopy, transthoracic needle&#xD;
      aspiration or surgical exploration to obtain a diagnosis. Intra thoracic malignancies&#xD;
      encompass lung cancers, thymomas and malignant pleural mesothelioma. These tumors often&#xD;
      present with pleural thickening, unilateral pleural effusion, mediastinal enlargement or a&#xD;
      peripheral located mass in the lungs. Tissue collection of the suspected pleural thickening&#xD;
      is required to assess a diagnosis and differentiate between the tumor types, to classify and&#xD;
      to stage in a proper manner. To date, the different biopsy methods, such as CT-guided pleural&#xD;
      biopsy, mediastinal biopsy, endosonography and thoracoscopy have their limitations in&#xD;
      diagnosing these malignancies. Sampling errors frequently occur resulting in the common&#xD;
      histological finding of 'non-specific pleuritic/fibrosis', which presents a great uncertainty&#xD;
      for clinicians and patients. Novel microscopic imaging techniques such as CLE are capable of&#xD;
      real time imaging on a cellular level. Data of CLE in intra-thoracic malignancies are&#xD;
      lacking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 28, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Technical feasibility: Number of successful procedures with evaluable CLE-imaging</measure>
    <time_frame>cross sectional (1 day)</time_frame>
    <description>Number of successful procedures with evaluable CLE-imaging</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procedure-related adverse events</measure>
    <time_frame>cross sectional (1 day)</time_frame>
    <description>Number of study-related adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To describe and develop visual descriptive image criteria (number of descriptive criteria based on CLE imaging)</measure>
    <time_frame>cross sectional (1 day)</time_frame>
    <description>Qualitative description of the number of descriptive criteria based on CLE imaging.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pleural Malignant Mesothelioma</condition>
  <condition>Thymoma</condition>
  <condition>Pleural Diseases</condition>
  <arm_group>
    <arm_group_label>Intrathoracic malignancy</arm_group_label>
    <description>Patients with (strong suspicion of) intrathoracic malignancy and an indication for tissue collection by CT-guided, transthoracic or thoracoscopic approach undergo additional imaging with confocal laser endomicroscopy (CLE).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Confocal laser endomicroscopy</intervention_name>
    <description>Real-time microscopic imaging technique</description>
    <arm_group_label>Intrathoracic malignancy</arm_group_label>
    <other_name>CLE</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with suspected intra-thoracic malignancies, who are referred for diagnostic&#xD;
        work-up by either transthoracic, thoracoscopic or endosonographic biopsy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  Supected intra-thoracic malignancies with pleural involvement and referred for a&#xD;
             diagnostic procedure by thoracoscopy, CT guided biopsy or endosonography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability and willingness to provide informed consent&#xD;
&#xD;
          -  Patients with known allergy for fluorescein or risk factors for an allergic reaction&#xD;
&#xD;
          -  pregnancy or lactating women&#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>Jouke Annema, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of respiratory medicine, Academic Medical Center Amsterdam</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>L Wijmans, MD</last_name>
    <phone>+31205667924</phone>
    <email>l.wijmans@amc.uva.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>M van de Pol, PhD</last_name>
    <phone>+31205661285</phone>
    <email>m.a.vandepol@amc.uva.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NKI-AvL</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Disselhorst, MD</last_name>
      <email>m.disselhorst@nki.nl</email>
    </contact>
    <investigator>
      <last_name>Paul Baas, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <state>Noordd-Holland</state>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Lizzy Wijmans, MD</last_name>
      <phone>0031205667924</phone>
      <email>l.wijmans@amc.nl</email>
    </contact>
    <contact_backup>
      <last_name>Marianne van de Pol, MD, PhD</last_name>
      <phone>0205661285</phone>
      <email>m.a.vandepol@amc.nl</email>
    </contact_backup>
    <investigator>
      <last_name>Jouke Annema, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lizzy Wijmans, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Prof J.T. Annema</investigator_full_name>
    <investigator_title>Head of pulmonary endoscopy department</investigator_title>
  </responsible_party>
  <keyword>Confocal laser endomicroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mesothelioma</mesh_term>
    <mesh_term>Mesothelioma, Malignant</mesh_term>
    <mesh_term>Thymoma</mesh_term>
    <mesh_term>Pleural Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>CLE imaging</ipd_description>
  </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/NCT03290183
org study id: NL60800.018.17
nct id: NCT03290183
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To date, the different biopsy methods, such as CT-guided pleural biopsy, mediastinal biopsy,
      endosonography and thoracoscopy have their limitations in diagnosing pleural malignancies,
      such as mesothelioma. Sampling errors frequently occur resulting in the common histological
      finding of 'non-specific pleuritic/fibrosis', which presents a great uncertainty for
      clinicians and patients. Confocal laser endomicroscopy (CLE) provides real-time imaging on a
      cellular level, however data of CLE in pleural malignancies are lacking.
Novel optical imaging techniques such as confocal laser endomicroscopy (CLE) have emerged in
      recent years as techniques that actually enable in vivo real-time microscopic analysis of
      malignancies of the GI-tract and lung cancer. Through recent advances the probe became small
      enough to fit through a biopsy needle and can be used during CT-guided and endosonographic
      guided biopsies (EUS-FNA). Patients with intra-thoracic malignancies often require invasive
      procedures such as bronchoscopy, thoracoscopy, mediastinoscopy, transthoracic needle
      aspiration or surgical exploration to obtain a diagnosis. Intra thoracic malignancies
      encompass lung cancers, thymomas and malignant pleural mesothelioma. These tumors often
      present with pleural thickening, unilateral pleural effusion, mediastinal enlargement or a
      peripheral located mass in the lungs. Tissue collection of the suspected pleural thickening
      is required to assess a diagnosis and differentiate between the tumor types, to classify and
      to stage in a proper manner. To date, the different biopsy methods, such as CT-guided pleural
      biopsy, mediastinal biopsy, endosonography and thoracoscopy have their limitations in
      diagnosing these malignancies. Sampling errors frequently occur resulting in the common
      histological finding of 'non-specific pleuritic/fibrosis', which presents a great uncertainty
      for clinicians and patients. Novel microscopic imaging techniques such as CLE are capable of
      real time imaging on a cellular level. Data of CLE in intra-thoracic malignancies are
      lacking.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Technical feasibility: Number of successful procedures with evaluable CLE-imaging
time frame: cross sectional (1 day)
description: Number of successful procedures with evaluable CLE-imaging
measure: Procedure-related adverse events
time frame: cross sectional (1 day)
description: Number of study-related adverse events
measure: To describe and develop visual descriptive image criteria (number of descriptive criteria based on CLE imaging)
time frame: cross sectional (1 day)
description: Qualitative description of the number of descriptive criteria based on CLE imaging.
arm group label: Intrathoracic malignancy
description: Patients with (strong suspicion of) intrathoracic malignancy and an indication for tissue collection by CT-guided, transthoracic or thoracoscopic approach undergo additional imaging with confocal laser endomicroscopy (CLE).
intervention type: Device
intervention name: Confocal laser endomicroscopy
description: Real-time microscopic imaging technique
arm group label: Intrathoracic malignancy
other name: CLE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jouke Annema, MD,PhD
role: Principal Investigator
affiliation: Department of respiratory medicine, Academic Medical Center Amsterdam
last name: L Wijmans, MD
phone: +31205667924
email: l.wijmans@amc.uva.nl
last name: M van de Pol, PhD
phone: +31205661285
email: m.a.vandepol@amc.uva.nl
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Prof J.T. Annema
investigator title: Head of pulmonary endoscopy department
mesh term: Mesothelioma
mesh term: Mesothelioma, Malignant
mesh term: Thymoma
mesh term: Pleural Diseases
sharing ipd: Yes
ipd description: CLE imaging