<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/NCT04441749</url>
  </required_header>
  <id_info>
    <org_study_id>20-1006</org_study_id>
    <secondary_id>TH-168</secondary_id>
    <nct_id>NCT04441749</nct_id>
  </id_info>
  <brief_title>nCLE For Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy</brief_title>
  <official_title>TH-168: Needle Based Confocal Laser Endomicroscopy For The Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fox Chase Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mauna Kea Technologies</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johnson &amp; Johnson</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fox Chase Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed&#xD;
      through a biopsy needle to enable real time microscopic imaging of cells. With resolution of&#xD;
      3.5 microns it is possible to identify key features consistent with malignancy and pulmonary&#xD;
      fibrosis. (Wijmans, et al., 2019). The effectiveness of nCLE with intravenous fluorescein has&#xD;
      been demonstrated in central lung cancers using esophageal ultrasound guided needle placement&#xD;
      (Wijmans, et al., 2019). In this study, the proposed nCLE lung cancer criteria had high&#xD;
      accuracy for lung cancer detection and were consistently recognized by multiple raters. Probe&#xD;
      based confocal microscopy (pCLE) has also been used in conjunction with a radial probe EBUS&#xD;
      in evaluating solitary pulmonary nodules with a diagnostic accuracy of 79.2%. (Hassan, et&#xD;
      al., 2017) Needle based confocal laser endomicroscopy (nCLE) has not previously been used in&#xD;
      conjunction with robotic navigational bronchoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">September 20, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ability to obtain good quality nCLE images of lung nodules</measure>
    <time_frame>1 year</time_frame>
    <description>Good quality nCLE images of lung nodules/ surrounding tissue in ≥80% of patients provided the peripheral lung nodule</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Diagnosis of Peripheral Lung Nodules</condition>
  <arm_group>
    <arm_group_label>nCLE Analysis</arm_group_label>
    <description>Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed through a biopsy needle to enable real time microscopic imaging of cells. With resolution of 3.5 microns it is possible to identify key features consistent with malignancy and pulmonary fibrosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)</intervention_name>
    <description>Patients who are scheduled to undergo Robotic Navigational Bronchoscopy for a peripheral lung lesion will be enrolled. During bronchoscopy, confocal images will be captured using Cellvizio 100 Series Confocal Laser Imaging systems and their Confocal Miniprobes (Mauna Kea Technologies Paris, France). The Cellvizio system and miniprobes are FDA approved by 510(k) for use in through the respiratory tracts by endoscopy or endoscopic accessories. Only images and needle aspiration/ biopsy results from the expansion phase (20 patients) will be analyzed</description>
    <arm_group_label>nCLE Analysis</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tissue lung nodule) acquisition by transbronchial needle aspiration/ biopsy (standard of&#xD;
      care)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be enrolled from outpatient pulmonary clinic and from direct referrals from&#xD;
        the inpatient pulmonary service and thoracic tumor board. Patients who scheduled to undergo&#xD;
        Robotic Navigational Bronchoscopy for a peripheral lung lesion at Fox Chase Fox Center will&#xD;
        be contacted to participate in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women, regardless of race, ethnic group or sexual orientation are eligible for&#xD;
             this study.&#xD;
&#xD;
          -  Patients undergoing robotic navigational bronchoscopy for evaluation of indeterminate&#xD;
             lung nodules with largest dimension size of 8-30 mm&#xD;
&#xD;
          -  Age &gt; 18 years.&#xD;
&#xD;
          -  Patients must have normal organ and marrow functions as defined below:&#xD;
&#xD;
        Leukocytes &gt; 3,000/mcL Absolute neutrophil count &gt; 1,500/mcL Total bilirubin within normal&#xD;
        institutional limits Hemoglobin ≥7.0 AST/ALT (SGOT/SGPT) &lt; 2 times institutional normal&#xD;
        limits Creatinine OR Creatinine Clearance within normal institutional limits OR &gt; 60&#xD;
        Ml/min/1.73 m2 for patients with creatinine levels above institutional normal&#xD;
&#xD;
          -  Ability to understand and willingness to sign a written informed consent and HIPAA&#xD;
             consent document&#xD;
&#xD;
          -  WOCBP must agree not to get pregnant until after the day of the procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with uncorrectable coagulopathy will be excluded.&#xD;
&#xD;
          -  Known allergy to fluorescein or other contrast media&#xD;
&#xD;
          -  Patients with hemodynamic instability will be excluded&#xD;
&#xD;
          -  Patients with refractory hypoxemia will be excluded&#xD;
&#xD;
          -  Patients with therapeutic anticoagulant that cannot be held for an appropriate&#xD;
             interval prior to the procedure&#xD;
&#xD;
          -  Patients who are unable to tolerate general anesthesia according to the&#xD;
             anesthesiologist&#xD;
&#xD;
          -  Patient requires chemotherapy&#xD;
&#xD;
          -  Pregnant or breast feeding. Refer to section 4.5 for further detail.&#xD;
&#xD;
          -  Subject has participated in an investigational drug or device research study within 30&#xD;
             days of enrollment that would interfere with this study&#xD;
&#xD;
          -  Pregnancy:&#xD;
&#xD;
        Women of child-bearing potential (WOCBP) who are pregnant on the day of the procedure will&#xD;
        be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam University Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <state>AZ</state>
        <zip>1105</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>February 3, 2023</last_update_submitted>
  <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT04441749
org study id: 20-1006
secondary id: TH-168
nct id: NCT04441749
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed
      through a biopsy needle to enable real time microscopic imaging of cells. With resolution of
      3.5 microns it is possible to identify key features consistent with malignancy and pulmonary
      fibrosis. (Wijmans, et al., 2019). The effectiveness of nCLE with intravenous fluorescein has
      been demonstrated in central lung cancers using esophageal ultrasound guided needle placement
      (Wijmans, et al., 2019). In this study, the proposed nCLE lung cancer criteria had high
      accuracy for lung cancer detection and were consistently recognized by multiple raters. Probe
      based confocal microscopy (pCLE) has also been used in conjunction with a radial probe EBUS
      in evaluating solitary pulmonary nodules with a diagnostic accuracy of 79.2%. (Hassan, et
      al., 2017) Needle based confocal laser endomicroscopy (nCLE) has not previously been used in
      conjunction with robotic navigational bronchoscopy.
observational model: Cohort
time perspective: Prospective
measure: Ability to obtain good quality nCLE images of lung nodules
time frame: 1 year
description: Good quality nCLE images of lung nodules/ surrounding tissue in ≥80% of patients provided the peripheral lung nodule
arm group label: nCLE Analysis
description: Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed through a biopsy needle to enable real time microscopic imaging of cells. With resolution of 3.5 microns it is possible to identify key features consistent with malignancy and pulmonary fibrosis
intervention type: Device
intervention name: Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)
description: Patients who are scheduled to undergo Robotic Navigational Bronchoscopy for a peripheral lung lesion will be enrolled. During bronchoscopy, confocal images will be captured using Cellvizio 100 Series Confocal Laser Imaging systems and their Confocal Miniprobes (Mauna Kea Technologies Paris, France). The Cellvizio system and miniprobes are FDA approved by 510(k) for use in through the respiratory tracts by endoscopy or endoscopic accessories. Only images and needle aspiration/ biopsy results from the expansion phase (20 patients) will be analyzed
arm group label: nCLE Analysis
Tissue lung nodule) acquisition by transbronchial needle aspiration/ biopsy (standard of
      care)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Netherlands
country: United States
responsible party type: Sponsor
mesh term: Disease