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To Evaluate Transoral Flexible Endoscope With Narrow Band Imaging in Nasopharyngeal Cancer

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transoral flexible endoscope with magnifying narrow band imaging
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

General Inclusion Criteria for both study groups, Test group and Control group.

  1. No previous radiotherapy to the head and neck region
  2. 18 Years and older
  3. Able to provide informed consent
  4. No cognitive impairment

Test group - Specific Inclusion Criteria 1) Newly diagnosed primary nasopharyngeal carcinoma

Control group - Specific Inclusion Criteria

1) Patients undergoing an OGD for lesions not involving disease of the head and neck region

General Exclusion Criteria for both study groups, Test group and Control group.

  1. On anticoagulation including Plavix, warfarin and NOAC's
  2. Current mucosal lesions of the head and neck region
  3. History of malignancy
  4. Concomitant malignant disease
  5. Trismus preventing an OGD

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    esophago-gastroscopy endoscopy with narrow band imaging

    Arm Description

    a transoral flexible endoscope with magnifying narrow band imaging in nasopharyngeal examination

    Outcomes

    Primary Outcome Measures

    The vasculature of the nasopharyngeal region
    The vasculature of the nasopharyngeal region which capture by the transoral flexible endoscope with magnifying narrow band imaging

    Secondary Outcome Measures

    Histological features of nasopharyngeal lesion
    Histological features of nasopharyngeal biopsy which is done during endoscopy with magnifying narrow band imaging.

    Full Information

    First Posted
    May 31, 2020
    Last Updated
    June 3, 2020
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04419324
    Brief Title
    To Evaluate Transoral Flexible Endoscope With Narrow Band Imaging in Nasopharyngeal Cancer
    Official Title
    A Pilot Study to Evaluate the Use of a Transoral Flexible Endoscope With Magnifying Narrow Band Imaging in Nasopharyngeal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2020 (Anticipated)
    Primary Completion Date
    May 2021 (Anticipated)
    Study Completion Date
    May 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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: Is it feasible to use an OGD with magnifying NBI for the diagnosis of NPC? Are there features detected on NBI OGD that are diagnostic of NPC? Do histological features correspond with NBI findings?
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasopharyngeal Carcinoma

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This is a case-control pilot study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    esophago-gastroscopy endoscopy with narrow band imaging
    Arm Type
    Other
    Arm Description
    a transoral flexible endoscope with magnifying narrow band imaging in nasopharyngeal examination
    Intervention Type
    Device
    Intervention Name(s)
    transoral flexible endoscope with magnifying narrow band imaging
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    The vasculature of the nasopharyngeal region
    Description
    The vasculature of the nasopharyngeal region which capture by the transoral flexible endoscope with magnifying narrow band imaging
    Time Frame
    during enrollment period
    Secondary Outcome Measure Information:
    Title
    Histological features of nasopharyngeal lesion
    Description
    Histological features of nasopharyngeal biopsy which is done during endoscopy with magnifying narrow band imaging.
    Time Frame
    during enrollment period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    General Inclusion Criteria for both study groups, Test group and Control group. No previous radiotherapy to the head and neck region 18 Years and older Able to provide informed consent No cognitive impairment Test group - Specific Inclusion Criteria 1) Newly diagnosed primary nasopharyngeal carcinoma Control group - Specific Inclusion Criteria 1) Patients undergoing an OGD for lesions not involving disease of the head and neck region General Exclusion Criteria for both study groups, Test group and Control group. On anticoagulation including Plavix, warfarin and NOAC's Current mucosal lesions of the head and neck region History of malignancy Concomitant malignant disease Trismus preventing an OGD
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cherrie NG
    Phone
    +852 35051409
    Email
    cherrieng@ent.cuhk.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jason Chan
    Organizational Affiliation
    Chinese University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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