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
About this trial
This is an interventional screening trial for Nasopharyngeal Carcinoma
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
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
NCT ID
NCT04419324
First Posted
May 31, 2020
Last Updated
June 3, 2020
Sponsor
Chinese University of Hong Kong
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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To Evaluate Transoral Flexible Endoscope With Narrow Band Imaging in Nasopharyngeal Cancer
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