<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/NCT01676012</url>
  </required_header>
  <id_info>
    <org_study_id>38719</org_study_id>
    <nct_id>NCT01676012</nct_id>
  </id_info>
  <brief_title>Hd-bronchoscopy, Comparison to Standard White Light and Autofluorescence Bronchoscopy</brief_title>
  <official_title>High Definition Bronchoscopy; an Exploratory Study of Diagnostic Value in Comparison to Standard White Light Bronchoscopy and Autofluorescence Bronchoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Through technological improvement a new technique has become available in the form of&#xD;
      high-definition (HD-) bronchoscopy. Current normal video white light bronchoscopy is the&#xD;
      standard, and video-autofluorescence bronchoscopy (AFB) is offered by specialized centers&#xD;
      only. The impact of this development with high-definition videobronchoscopy using a 1.1&#xD;
      megapixel chip on the diagnostic performance of bronchoscopy is however unknown.&#xD;
&#xD;
      The aim of the present study therefore is to explore the diagnostic performance (sensitivity&#xD;
      and specificity) of HD-videobronchoscopy, HD + surface enhancement (iScan filtering&#xD;
      technique) and HD + tone enhancement filtering in comparison to standard WLB and dual mode&#xD;
      SAFE3000 autofluorescence videobronchoscopy in a high risk population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale Bronchoscopy is one of the most important procedures in diagnosis of lung cancer&#xD;
      and other pulmonary diseases. This procedures renders important anatomical information and&#xD;
      subtle changes in the epithelium or vascularity of the bronchial tree are clues to guide the&#xD;
      endoscopist in this procedure, especially in case of centrally located lung cancer. These&#xD;
      subtle changes may influence the choice of treatment, site of biopsy and resectability of&#xD;
      cancers when determining resection margins but also in case of multifocal premalignant&#xD;
      disease. A recently published meta-analysis has shown diagnostic superiority of&#xD;
      autofluorescence bronchoscopy (AFB) over routine white light bronchoscopy (WLB). Furthermore,&#xD;
      patients with a head and neck cancer have an increased risk of developing lung cancer given&#xD;
      their smoking habits. Through technological improvement a new technique has become available&#xD;
      in the form of high-definition (HD-) bronchoscopy. Current normal video white light&#xD;
      bronchoscopy is the standard, and video-autofluorescence bronchoscopy (AFB) is offered by&#xD;
      specialized centers only. The impact of this development with high-definition&#xD;
      videobronchoscopy using a 1.1 megapixel chip on the diagnostic performance of bronchoscopy is&#xD;
      however unknown.&#xD;
&#xD;
      Objective (primary and secondary outcome)&#xD;
&#xD;
      (1) Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone&#xD;
      enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting&#xD;
      abnormalities of the tracheobronchial tree. Furthermore we aim to investigate determination&#xD;
      of resection margins of (suspected) malignancies in the glottic and supraglottic area or&#xD;
      centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual&#xD;
      video mode) in a high risk population with biopsies from all suspect lesions identified by&#xD;
      either technique. (2) When the sensitivity and specificity of HD videobronchoscopy in either&#xD;
      mode in the abovementioned study is in the vicinity of the reported sensitivity and&#xD;
      specificity of SAFE3000 dual mode videobronchoscopy we suggest to use the results of this&#xD;
      study perform a power analysis. With this information it may then be possible to design a new&#xD;
      future study to compare sensitivity for detecting premalignant lesions in a high risk&#xD;
      population in a prospective study.&#xD;
&#xD;
      Study design This study is a descriptive exploratory randomized observational study with a&#xD;
      blinded post procedure analysis of the diagnostic performance of HD bronchoscopy in&#xD;
      comparison to WLB and AFB.&#xD;
&#xD;
      Study population Patients scheduled for diagnostic or therapeutic procedure under general&#xD;
      anesthesia by the cardiothoracic or thoracic surgeon or ear-, nose- and throat (ENT) surgeon&#xD;
      with suspected or proven lung cancer or head and neck cancer are eligible for this&#xD;
      exploratory study. Eligible are patients with ASA physical status 1-3 patients aged 18 years&#xD;
      or older. Ineligibility criteria are all known contraindications for diagnostic bronchoscopy&#xD;
      (bleeding disorders, indication for use of anticoagulant therapy (acenocoumarol, warfarins,&#xD;
      therapeutic dose of low molecular weight heparins or clopidogrel), known allergy for&#xD;
      lidocaine, known pulmonary hypertension, recent and/or uncontrolled cardiac disease).&#xD;
      Presence of contraindications for the use of laryngeal mask (anatomical abnormalities,&#xD;
      increased risk for intubation (mallampati score 4), ASA classification greater than or equal&#xD;
      to 4.&#xD;
&#xD;
      Study procedure Prior to surgery by the ENT surgeon or cardiothoracic surgeon bronchoscopy&#xD;
      will be performed by an experienced chest physician through a laryngeal mask under general&#xD;
      anaesthesia. Bronchoscopy will be performed in a standardized order using five different&#xD;
      imaging modes. The order of the different modes will be randomized. High-definition digital&#xD;
      videos will be made from all procedures without in screen indications of date, time or&#xD;
      reference to study site or patient identification. The five imaging modes used in this study&#xD;
      are: Standard white light videobronchoscopy (WLB); High Definition (HD-) bronchoscopy;&#xD;
      HD-bronchoscopy + surface enhancement; HD-bronchoscopy + tone enhancement and Auto&#xD;
      Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode. All visible abnormalities&#xD;
      suspected for malignancy or pre-malignancy will be biopsied afterwards. The HD-digital&#xD;
      video's will be reviewed by the experienced bronchoscopists in random order and blinded for&#xD;
      patient, study site and date and scored using a predefined scoring system to describe&#xD;
      surface, vascularity and tumours. Premalignant lesions identified by multiple techniques are&#xD;
      considered as non-inferior. From each patient 5 HD- films will be generated. These films will&#xD;
      be reviewed in a blinded fashion and random order by two experienced pulmonologists and an&#xD;
      independent equally experienced third pulmonologist. When new clinically relevant&#xD;
      abnormalities are found the normally indicated diagnostic procedures will be followed and&#xD;
      performed immediately after completion of the videoregistration. All findings will be&#xD;
      disclosed to the patient and the physician in charge by the investigator and the impact of&#xD;
      these findings on the planned diagnostic or therapeutic procedure will be registered.&#xD;
&#xD;
      Main study parameter / endpoints The bronchoscopy videos will be scored by blinded&#xD;
      experienced endoscopists on epithelial changes, vascularity changes, presence or suspicion of&#xD;
      dysplasia, presence of suspicion of carcinoma in situ, and tumor margins. The study is a&#xD;
      descriptive exploratory study of diagnostic performance of HD-bronchoscopy using different&#xD;
      imaging techniques in comparison to standard white light bronchoscopy and autofluorescence&#xD;
      bronchoscopy in determining epithelial changes, changes in vascularity and tumour margins. As&#xD;
      a secondary outcome we aim, when differences are established between the different&#xD;
      bronchoscopy modes, to perform a power analysis to determine the feasibility of a&#xD;
      prospectively designed study to investigate the diagnostic performance of HD bronchoscopy.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness After start of the general anaesthesia for the planned operation a laryngeal mask&#xD;
      airway is inserted by the anesthesiologist. Bronchoscopy is then performed by a very&#xD;
      experienced pulmonologist using routine topical anesthesics. In this way the burden for the&#xD;
      patient and the risk of complications is very low. These patients have an indication for the&#xD;
      planned surgical procedure and have been evaluated by an anesthesiologist prior to the&#xD;
      procedure and are considered fit for surgery. The total anesthesia time for the planned&#xD;
      procedure will be increased by 10 to 15 minutes.&#xD;
&#xD;
      Bronchoscopy is a very safe diagnostic procedure, the reported complications are in general&#xD;
      attributable to te more invasive diagnostic procedures performed during that diagnostic&#xD;
      bronchoscopy like biopsy, lavage and needle aspirations. This is not the aim of this study,&#xD;
      invasive diagnostic procedures will only be performed in case of a clinically relevant new&#xD;
      finding. In general we expect that the vast majority of the patients involved will not have&#xD;
      any benefit of participating in this study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Sensitivity</measure>
    <time_frame>one year</time_frame>
    <description>Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting abnormalities of the tracheobronchial tree. So we used 5 types of bronchoscopy; SWL (=standard white light), HD (=high defenition bronchoscopy without surface/tone enhancement), HD-i-Scan1 (=high defention bronchoscopy with surface enhancement), HD-i-scan 2 (=high defenition bronchoscopy with tone enhancement), AFB (=autofluorescence bronchoscopy). Furthermore we aim to investigate determination of resection margins of (suspected) malignancies in the glottic and supraglottic area or centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual video mode) in a high risk population with biopsies from all suspect lesions identified by either technique.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and Specificity of HD Videobronchoscopy</measure>
    <time_frame>one year</time_frame>
    <description>When the sensitivity and specificity of HD videobronchoscopy in either mode in the abovementioned study is in the vicinity of the reported sensitivity and specificity of SAFE3000 dual mode videobronchoscopy we suggest to use the results of this study perform a power analysis. With this information it may then be possible to design a new future study to compare sensitivity for detecting premalignant lesions in a high risk population in a prospective study.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>five types of bronchoscopy</arm_group_label>
    <description>Bronchoscopy will be performed in a standardized order using five different imaging modes.&#xD;
Standard white light videobronchoscopy (WLB)&#xD;
High Definition -Bronchoscopy&#xD;
HD-bronchoscopy + surface enhancement (iScan-surface)&#xD;
HD-bronchoscopy + tone enhancement (iScan-tone)&#xD;
Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with suspected or proven head and neck or lung cancer fit for surgery and&#xD;
        scheduled for diagnostic or therapeutic surgical procedure in the Radboud University&#xD;
        Medical Center Nijmegen&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients fit for surgery and scheduled for diagnostic or therapeutic surgical&#xD;
             procedure under general anesthesia by the cardiothoracic or thoracic surgeon or ENT&#xD;
             surgeon with suspected or proven lung cancer or head and neck cancer.&#xD;
&#xD;
          -  ASA physical status 1-3.&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Contraindications are all known contraindications for diagnostic bronchoscopy such as:&#xD;
&#xD;
          -  bleeding disorders,&#xD;
&#xD;
          -  indication for use of anticoagulant therapy (acenocoumarol, warfarins, therapeutic&#xD;
             dose of low molecular weight heparins or clopidogrel),&#xD;
&#xD;
          -  known allergy for lidocaine,&#xD;
&#xD;
          -  known pulmonary hypertension,&#xD;
&#xD;
          -  recent and/or uncontrolled cardiac disease. Presence of contraindications for the use&#xD;
             of laryngeal mask (anatomical abnormalities) increased risk for intubation (mallampati&#xD;
             score 4), or compromised upper airway due to extension of primary head and neck&#xD;
             cancer.&#xD;
&#xD;
        ASA classification greater than or equal to 4.&#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>HFM vanderHeijden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboud University Medical Center Nijmegen</name>
      <address>
        <city>Nijmegen</city>
        <state>Geert Grooteplein 10</state>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>March 17, 2015</results_first_submitted>
  <results_first_submitted_qc>May 8, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 12, 2015</results_first_posted>
  <last_update_submitted>May 8, 2015</last_update_submitted>
  <last_update_submitted_qc>May 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Bronchoscopy will be performed in a standardized order using five different imaging modes.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Five Types of Bronchoscopy</title>
          <description>Standard white light videobronchoscopy (WLB)&#xD;
High Definition -Bronchoscopy&#xD;
HD-bronchoscopy + surface enhancement (iScan-surface)&#xD;
HD-bronchoscopy + tone enhancement (iScan-tone)&#xD;
Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>incomplete set of videos</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>A total of 32 patients were enrolled. Two patients had a insecure airway so bronchoscopy was performed in 30 patients and a complete set of videos was available for analysis in 29 patients.</population>
      <group_list>
        <group group_id="B1">
          <title>Five Types of Bronchoscopy</title>
          <description>Bronchoscopy will be performed in a standardized order using five different imaging modes.&#xD;
Standard white light videobronchoscopy (WLB)&#xD;
High Definition -Bronchoscopy&#xD;
HD-bronchoscopy + surface enhancement (iScan-surface)&#xD;
HD-bronchoscopy + tone enhancement (iScan-tone)&#xD;
Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63" lower_limit="40" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sensitivity</title>
        <description>Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting abnormalities of the tracheobronchial tree. So we used 5 types of bronchoscopy; SWL (=standard white light), HD (=high defenition bronchoscopy without surface/tone enhancement), HD-i-Scan1 (=high defention bronchoscopy with surface enhancement), HD-i-scan 2 (=high defenition bronchoscopy with tone enhancement), AFB (=autofluorescence bronchoscopy). Furthermore we aim to investigate determination of resection margins of (suspected) malignancies in the glottic and supraglottic area or centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual video mode) in a high risk population with biopsies from all suspect lesions identified by either technique.</description>
        <time_frame>one year</time_frame>
        <population>Vascular abnormalities were scored most frequently in HD + i-scan2 bronchoscopy. Sites suspicious for preinvasive lesions were most frequently reported using AFB. Tumors were detected equally by all modalities. The preferred modality was HD bronchoscopy with i-scan.</population>
        <group_list>
          <group group_id="O1">
            <title>Five Types of Bronchoscopy</title>
            <description>Bronchoscopy will be performed in a standardized order using five different imaging modes.&#xD;
Standard white light videobronchoscopy (WLB)&#xD;
High Definition -Bronchoscopy&#xD;
HD-bronchoscopy + surface enhancement (iScan-surface)&#xD;
HD-bronchoscopy + tone enhancement (iScan-tone)&#xD;
Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode</description>
          </group>
        </group_list>
        <measure>
          <title>Sensitivity</title>
          <description>Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting abnormalities of the tracheobronchial tree. So we used 5 types of bronchoscopy; SWL (=standard white light), HD (=high defenition bronchoscopy without surface/tone enhancement), HD-i-Scan1 (=high defention bronchoscopy with surface enhancement), HD-i-scan 2 (=high defenition bronchoscopy with tone enhancement), AFB (=autofluorescence bronchoscopy). Furthermore we aim to investigate determination of resection margins of (suspected) malignancies in the glottic and supraglottic area or centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual video mode) in a high risk population with biopsies from all suspect lesions identified by either technique.</description>
          <population>Vascular abnormalities were scored most frequently in HD + i-scan2 bronchoscopy. Sites suspicious for preinvasive lesions were most frequently reported using AFB. Tumors were detected equally by all modalities. The preferred modality was HD bronchoscopy with i-scan.</population>
          <units># vascular sites detected per patient</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>standard white light</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.72" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HD-i-scan1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.78" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hd-i-scan2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sensitivity and Specificity of HD Videobronchoscopy</title>
        <description>When the sensitivity and specificity of HD videobronchoscopy in either mode in the abovementioned study is in the vicinity of the reported sensitivity and specificity of SAFE3000 dual mode videobronchoscopy we suggest to use the results of this study perform a power analysis. With this information it may then be possible to design a new future study to compare sensitivity for detecting premalignant lesions in a high risk population in a prospective study.</description>
        <time_frame>one year</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>11 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Five Types of Bronchoscopy</title>
          <description>Bronchoscopy will be performed in a standardized order using five different imaging modes.&#xD;
Standard white light videobronchoscopy (WLB)&#xD;
High Definition -Bronchoscopy&#xD;
HD-bronchoscopy + surface enhancement (iScan-surface)&#xD;
HD-bronchoscopy + tone enhancement (iScan-tone)&#xD;
Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>vocal cord pathology</sub_title>
                <description>After sedation patient was unable to ventilate adequate due to vocal cord pathology. Study procedures were not started.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>prolonged hospitalisiation</sub_title>
                <description>After study procedures larynx was lasered. Due to that procedure patient developed oedema wich coused a inspiratory stridor.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Erik van der Heijden</name_or_title>
      <organization>Radboudumc</organization>
      <phone>0031243614579</phone>
      <email>Erik.vanderHeijden@radboudumc.nl</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01676012
org study id: 38719
nct id: NCT01676012
lead sponsor: 
has dmc: No
Through technological improvement a new technique has become available in the form of
      high-definition (HD-) bronchoscopy. Current normal video white light bronchoscopy is the
      standard, and video-autofluorescence bronchoscopy (AFB) is offered by specialized centers
      only. The impact of this development with high-definition videobronchoscopy using a 1.1
      megapixel chip on the diagnostic performance of bronchoscopy is however unknown.

      The aim of the present study therefore is to explore the diagnostic performance (sensitivity
      and specificity) of HD-videobronchoscopy, HD + surface enhancement (iScan filtering
      technique) and HD + tone enhancement filtering in comparison to standard WLB and dual mode
      SAFE3000 autofluorescence videobronchoscopy in a high risk population.
Rationale Bronchoscopy is one of the most important procedures in diagnosis of lung cancer
      and other pulmonary diseases. This procedures renders important anatomical information and
      subtle changes in the epithelium or vascularity of the bronchial tree are clues to guide the
      endoscopist in this procedure, especially in case of centrally located lung cancer. These
      subtle changes may influence the choice of treatment, site of biopsy and resectability of
      cancers when determining resection margins but also in case of multifocal premalignant
      disease. A recently published meta-analysis has shown diagnostic superiority of
      autofluorescence bronchoscopy (AFB) over routine white light bronchoscopy (WLB). Furthermore,
      patients with a head and neck cancer have an increased risk of developing lung cancer given
      their smoking habits. Through technological improvement a new technique has become available
      in the form of high-definition (HD-) bronchoscopy. Current normal video white light
      bronchoscopy is the standard, and video-autofluorescence bronchoscopy (AFB) is offered by
      specialized centers only. The impact of this development with high-definition
      videobronchoscopy using a 1.1 megapixel chip on the diagnostic performance of bronchoscopy is
      however unknown.

      Objective (primary and secondary outcome)

      (1) Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone
      enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting
      abnormalities of the tracheobronchial tree. Furthermore we aim to investigate determination
      of resection margins of (suspected) malignancies in the glottic and supraglottic area or
      centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual
      video mode) in a high risk population with biopsies from all suspect lesions identified by
      either technique. (2) When the sensitivity and specificity of HD videobronchoscopy in either
      mode in the abovementioned study is in the vicinity of the reported sensitivity and
      specificity of SAFE3000 dual mode videobronchoscopy we suggest to use the results of this
      study perform a power analysis. With this information it may then be possible to design a new
      future study to compare sensitivity for detecting premalignant lesions in a high risk
      population in a prospective study.

      Study design This study is a descriptive exploratory randomized observational study with a
      blinded post procedure analysis of the diagnostic performance of HD bronchoscopy in
      comparison to WLB and AFB.

      Study population Patients scheduled for diagnostic or therapeutic procedure under general
      anesthesia by the cardiothoracic or thoracic surgeon or ear-, nose- and throat (ENT) surgeon
      with suspected or proven lung cancer or head and neck cancer are eligible for this
      exploratory study. Eligible are patients with ASA physical status 1-3 patients aged 18 years
      or older. Ineligibility criteria are all known contraindications for diagnostic bronchoscopy
      (bleeding disorders, indication for use of anticoagulant therapy (acenocoumarol, warfarins,
      therapeutic dose of low molecular weight heparins or clopidogrel), known allergy for
      lidocaine, known pulmonary hypertension, recent and/or uncontrolled cardiac disease).
      Presence of contraindications for the use of laryngeal mask (anatomical abnormalities,
      increased risk for intubation (mallampati score 4), ASA classification greater than or equal
      to 4.

      Study procedure Prior to surgery by the ENT surgeon or cardiothoracic surgeon bronchoscopy
      will be performed by an experienced chest physician through a laryngeal mask under general
      anaesthesia. Bronchoscopy will be performed in a standardized order using five different
      imaging modes. The order of the different modes will be randomized. High-definition digital
      videos will be made from all procedures without in screen indications of date, time or
      reference to study site or patient identification. The five imaging modes used in this study
      are: Standard white light videobronchoscopy (WLB); High Definition (HD-) bronchoscopy;
      HD-bronchoscopy + surface enhancement; HD-bronchoscopy + tone enhancement and Auto
      Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode. All visible abnormalities
      suspected for malignancy or pre-malignancy will be biopsied afterwards. The HD-digital
      video's will be reviewed by the experienced bronchoscopists in random order and blinded for
      patient, study site and date and scored using a predefined scoring system to describe
      surface, vascularity and tumours. Premalignant lesions identified by multiple techniques are
      considered as non-inferior. From each patient 5 HD- films will be generated. These films will
      be reviewed in a blinded fashion and random order by two experienced pulmonologists and an
      independent equally experienced third pulmonologist. When new clinically relevant
      abnormalities are found the normally indicated diagnostic procedures will be followed and
      performed immediately after completion of the videoregistration. All findings will be
      disclosed to the patient and the physician in charge by the investigator and the impact of
      these findings on the planned diagnostic or therapeutic procedure will be registered.

      Main study parameter / endpoints The bronchoscopy videos will be scored by blinded
      experienced endoscopists on epithelial changes, vascularity changes, presence or suspicion of
      dysplasia, presence of suspicion of carcinoma in situ, and tumor margins. The study is a
      descriptive exploratory study of diagnostic performance of HD-bronchoscopy using different
      imaging techniques in comparison to standard white light bronchoscopy and autofluorescence
      bronchoscopy in determining epithelial changes, changes in vascularity and tumour margins. As
      a secondary outcome we aim, when differences are established between the different
      bronchoscopy modes, to perform a power analysis to determine the feasibility of a
      prospectively designed study to investigate the diagnostic performance of HD bronchoscopy.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness After start of the general anaesthesia for the planned operation a laryngeal mask
      airway is inserted by the anesthesiologist. Bronchoscopy is then performed by a very
      experienced pulmonologist using routine topical anesthesics. In this way the burden for the
      patient and the risk of complications is very low. These patients have an indication for the
      planned surgical procedure and have been evaluated by an anesthesiologist prior to the
      procedure and are considered fit for surgery. The total anesthesia time for the planned
      procedure will be increased by 10 to 15 minutes.

      Bronchoscopy is a very safe diagnostic procedure, the reported complications are in general
      attributable to te more invasive diagnostic procedures performed during that diagnostic
      bronchoscopy like biopsy, lavage and needle aspirations. This is not the aim of this study,
      invasive diagnostic procedures will only be performed in case of a clinically relevant new
      finding. In general we expect that the vast majority of the patients involved will not have
      any benefit of participating in this study
observational model: Case-Only
time perspective: Cross-Sectional
measure: Sensitivity
time frame: one year
description: Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting abnormalities of the tracheobronchial tree. So we used 5 types of bronchoscopy; SWL (=standard white light), HD (=high defenition bronchoscopy without surface/tone enhancement), HD-i-Scan1 (=high defention bronchoscopy with surface enhancement), HD-i-scan 2 (=high defenition bronchoscopy with tone enhancement), AFB (=autofluorescence bronchoscopy). Furthermore we aim to investigate determination of resection margins of (suspected) malignancies in the glottic and supraglottic area or centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual video mode) in a high risk population with biopsies from all suspect lesions identified by either technique.
measure: Sensitivity and Specificity of HD Videobronchoscopy
time frame: one year
description: When the sensitivity and specificity of HD videobronchoscopy in either mode in the abovementioned study is in the vicinity of the reported sensitivity and specificity of SAFE3000 dual mode videobronchoscopy we suggest to use the results of this study perform a power analysis. With this information it may then be possible to design a new future study to compare sensitivity for detecting premalignant lesions in a high risk population in a prospective study.
arm group label: five types of bronchoscopy
description: Bronchoscopy will be performed in a standardized order using five different imaging modes.
Standard white light videobronchoscopy (WLB)
High Definition -Bronchoscopy
HD-bronchoscopy + surface enhancement (iScan-surface)
HD-bronchoscopy + tone enhancement (iScan-tone)
Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: HFM vanderHeijden, MD
role: Principal Investigator
affiliation: Principal Investigator
facility: 
country: Netherlands
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 