<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/NCT04419324</url>
  </required_header>
  <id_info>
    <org_study_id>01</org_study_id>
    <nct_id>NCT04419324</nct_id>
  </id_info>
  <brief_title>To Evaluate Transoral Flexible Endoscope With Narrow Band Imaging in Nasopharyngeal Cancer</brief_title>
  <official_title>A Pilot Study to Evaluate the Use of a Transoral Flexible Endoscope With Magnifying Narrow Band Imaging in Nasopharyngeal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      Nasopharyngeal carcinoma (NPC) is endemic in our region and is the 9th most common cancer in&#xD;
      Hong Kong. Traditionally diagnosis has been through a nasoendoscopic examination of the&#xD;
      nasopharynx with white light followed by a biopsy of suspicious lesions for a confirmatory&#xD;
      diagnosis. However, given the geometry of the anatomy of the nasopharynx, with its inherent&#xD;
      crevices and varying amounts of lymphoid tissues, lesions are not always easily identified&#xD;
      leading to potential missed lesions. The non-specific aspect of white light also leads to&#xD;
      excessive biopsies that are not without risk and of some discomfort to patients. Recent&#xD;
      advances in liquid biopsies have also allowed for the detection of earlier and smaller&#xD;
      lesions that are not always easily identified on nasoendoscopy but rather are seen on&#xD;
      Magnetic Resonance Imaging (MRI)1 .&#xD;
&#xD;
      An alternative imaging technique is the use of Narrow Band Imaging (NBI) to view the&#xD;
      vasculature of the mucosa to identify suspicious lesions for pre-malignancy and malignancy&#xD;
      that has been popularized in the gastrointestinal tract. In NPC, NBI with the flexible&#xD;
      nasoendoscopes has been used in the diagnosis of NPC with varying success2-5 . Our own&#xD;
      group's research has found that in NPC NBI has limitations arising from a lack of consensus&#xD;
      on vascular findings on NBI that constitute malignancy, lack of magnification and long focal&#xD;
      length of current nasoendoscopes5-8 . Flexible endoscopy using conventional&#xD;
      esophago-gastroscopy endoscope (OGD) with NBI and magnification power up to 80x overcome the&#xD;
      limitations of current nasoendoscopes, however their size precludes the passing of these&#xD;
      endoscopes through the nasal cavity.&#xD;
&#xD;
      Here in this pilot study we will seek to use an OGD with NBI passed transorally and&#xD;
      retroflexed into the nasopharynx to view the nasopharynx with increased magnification and&#xD;
      clarity to evaluate the feasibility of this study in the diagnosis of nasopharyngeal&#xD;
      carcinoma.&#xD;
&#xD;
      Study questions:&#xD;
&#xD;
        1. Is it feasible to use an OGD with magnifying NBI for the diagnosis of NPC?&#xD;
&#xD;
        2. Are there features detected on NBI OGD that are diagnostic of NPC?&#xD;
&#xD;
        3. Do histological features correspond with NBI findings?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a case-control pilot study. We will recruit 40 patients. 20 patients with newly&#xD;
      diagnosed primary NPC will be recruited to the test group. 20 patients undergoing an OGD for&#xD;
      lesions not involving disease of the head and neck region will be recruited to the control&#xD;
      group.&#xD;
&#xD;
      NBI OGD and flexible nasoendoscopy will be performed to examine patients' nasopharyngeal&#xD;
      region.&#xD;
&#xD;
      NBI OGD: Endoscopic procedures would be performed by our investigators with expertise on&#xD;
      performing upper endoscopy. Endoscopes with magnification and NBI function would be used&#xD;
      (GF-H290Z, Olympus Medical Corporations, Tokyo, Japan). A soft black hood would be attached&#xD;
      to the tip of the endoscope for better focal length adjustment.&#xD;
&#xD;
      Upon insertion through a mouthpiece, the scope will then be retroflexed into the nasopharynx&#xD;
      and the lateral walls into the Fossa of Rosenmuller and the posterior nasopharyngeal wall&#xD;
      will be systematically examined with white light and NBI. Target suspicious areas would be&#xD;
      examined by use of magnification with the power up to 80X.&#xD;
&#xD;
      Flexible nasoendoscopy: The nasoendoscope is introduced into the nose, the nasal cavity and&#xD;
      nasopharyngnx. It has a camera and a light at the end and allows our doctor to check for any&#xD;
      abnormal looking areas. Upon identification of suspicious lesion. Biopsies of sites with&#xD;
      different NBI findings will be taken to correlate the NBI findings with histological&#xD;
      features.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">May 2021</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>
    <intervention_model_description>This is a case-control pilot study</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The vasculature of the nasopharyngeal region</measure>
    <time_frame>during enrollment period</time_frame>
    <description>The vasculature of the nasopharyngeal region which capture by the transoral flexible endoscope with magnifying narrow band imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histological features of nasopharyngeal lesion</measure>
    <time_frame>during enrollment period</time_frame>
    <description>Histological features of nasopharyngeal biopsy which is done during endoscopy with magnifying narrow band imaging.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>esophago-gastroscopy endoscopy with narrow band imaging</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>a transoral flexible endoscope with magnifying narrow band imaging in nasopharyngeal examination</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transoral flexible endoscope with magnifying narrow band imaging</intervention_name>
    <description>To use an esophago-gastroscopy endoscope (OGD) with Narrow Band Imaging (NBI) passed transorally and retroflexed into the nasopharynx to view the nasopharynx with increased magnification and clarity for the diagnosis of nasopharyngeal carcinoma.</description>
    <arm_group_label>esophago-gastroscopy endoscopy with narrow band imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General Inclusion Criteria for both study groups, Test group and Control group.&#xD;
&#xD;
          1. No previous radiotherapy to the head and neck region&#xD;
&#xD;
          2. 18 Years and older&#xD;
&#xD;
          3. Able to provide informed consent&#xD;
&#xD;
          4. No cognitive impairment&#xD;
&#xD;
        Test group - Specific Inclusion Criteria 1) Newly diagnosed primary nasopharyngeal&#xD;
        carcinoma&#xD;
&#xD;
        Control group - Specific Inclusion Criteria&#xD;
&#xD;
        1) Patients undergoing an OGD for lesions not involving disease of the head and neck region&#xD;
&#xD;
        General Exclusion Criteria for both study groups, Test group and Control group.&#xD;
&#xD;
          1. On anticoagulation including Plavix, warfarin and NOAC's&#xD;
&#xD;
          2. Current mucosal lesions of the head and neck region&#xD;
&#xD;
          3. History of malignancy&#xD;
&#xD;
          4. Concomitant malignant disease&#xD;
&#xD;
          5. Trismus preventing an OGD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Chan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cherrie NG</last_name>
    <phone>+852 35051409</phone>
    <email>cherrieng@ent.cuhk.edu.hk</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Jason Chan</investigator_full_name>
    <investigator_title>Prof. Chan, Jason Ying Kuen</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04419324
org study id: 01
nct id: NCT04419324
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Nasopharyngeal carcinoma (NPC) is endemic in our region and is the 9th most common cancer in
      Hong Kong. Traditionally diagnosis has been through a nasoendoscopic examination of the
      nasopharynx with white light followed by a biopsy of suspicious lesions for a confirmatory
      diagnosis. However, given the geometry of the anatomy of the nasopharynx, with its inherent
      crevices and varying amounts of lymphoid tissues, lesions are not always easily identified
      leading to potential missed lesions. The non-specific aspect of white light also leads to
      excessive biopsies that are not without risk and of some discomfort to patients. Recent
      advances in liquid biopsies have also allowed for the detection of earlier and smaller
      lesions that are not always easily identified on nasoendoscopy but rather are seen on
      Magnetic Resonance Imaging (MRI)1 .

      An alternative imaging technique is the use of Narrow Band Imaging (NBI) to view the
      vasculature of the mucosa to identify suspicious lesions for pre-malignancy and malignancy
      that has been popularized in the gastrointestinal tract. In NPC, NBI with the flexible
      nasoendoscopes has been used in the diagnosis of NPC with varying success2-5 . Our own
      group's research has found that in NPC NBI has limitations arising from a lack of consensus
      on vascular findings on NBI that constitute malignancy, lack of magnification and long focal
      length of current nasoendoscopes5-8 . Flexible endoscopy using conventional
      esophago-gastroscopy endoscope (OGD) with NBI and magnification power up to 80x overcome the
      limitations of current nasoendoscopes, however their size precludes the passing of these
      endoscopes through the nasal cavity.

      Here in this pilot study we will seek to use an OGD with NBI passed transorally and
      retroflexed into the nasopharynx to view the nasopharynx with increased magnification and
      clarity to evaluate the feasibility of this study in the diagnosis of nasopharyngeal
      carcinoma.

      Study questions:

        1. Is it feasible to use an OGD with magnifying NBI for the diagnosis of NPC?

        2. Are there features detected on NBI OGD that are diagnostic of NPC?

        3. Do histological features correspond with NBI findings?
This is a case-control pilot study. We will recruit 40 patients. 20 patients with newly
      diagnosed primary NPC will be recruited to the test group. 20 patients undergoing an OGD for
      lesions not involving disease of the head and neck region will be recruited to the control
      group.

      NBI OGD and flexible nasoendoscopy will be performed to examine patients' nasopharyngeal
      region.

      NBI OGD: Endoscopic procedures would be performed by our investigators with expertise on
      performing upper endoscopy. Endoscopes with magnification and NBI function would be used
      (GF-H290Z, Olympus Medical Corporations, Tokyo, Japan). A soft black hood would be attached
      to the tip of the endoscope for better focal length adjustment.

      Upon insertion through a mouthpiece, the scope will then be retroflexed into the nasopharynx
      and the lateral walls into the Fossa of Rosenmuller and the posterior nasopharyngeal wall
      will be systematically examined with white light and NBI. Target suspicious areas would be
      examined by use of magnification with the power up to 80X.

      Flexible nasoendoscopy: The nasoendoscope is introduced into the nose, the nasal cavity and
      nasopharyngnx. It has a camera and a light at the end and allows our doctor to check for any
      abnormal looking areas. Upon identification of suspicious lesion. Biopsies of sites with
      different NBI findings will be taken to correlate the NBI findings with histological
      features.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a case-control pilot study
primary purpose: Screening
masking: None (Open Label)
measure: The vasculature of the nasopharyngeal region
time frame: during enrollment period
description: The vasculature of the nasopharyngeal region which capture by the transoral flexible endoscope with magnifying narrow band imaging
measure: Histological features of nasopharyngeal lesion
time frame: during enrollment period
description: Histological features of nasopharyngeal biopsy which is done during endoscopy with magnifying narrow band imaging.
arm group label: esophago-gastroscopy endoscopy with narrow band imaging
arm group type: Other
description: a transoral flexible endoscope with magnifying narrow band imaging in nasopharyngeal examination
intervention type: Device
intervention name: transoral flexible endoscope with magnifying narrow band imaging
description: To use an esophago-gastroscopy endoscope (OGD) with Narrow Band Imaging (NBI) passed transorally and retroflexed into the nasopharynx to view the nasopharynx with increased magnification and clarity for the diagnosis of nasopharyngeal carcinoma.
arm group label: esophago-gastroscopy endoscopy with narrow band imaging
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jason Chan
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: Cherrie NG
phone: +852 35051409
email: cherrieng@ent.cuhk.edu.hk
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Jason Chan
investigator title: Prof. Chan, Jason Ying Kuen
mesh term: Nasopharyngeal Carcinoma
mesh term: Nasopharyngeal Neoplasms
sharing ipd: No