Nasopharyngeal CarcinomaNCT04419324
To Evaluate Transoral Flexible Endoscope With Narrow Band Imaging in Nasopharyngeal Cancer
A study testing transoral flexible endoscope with magnifying narrow band imaging in people with Nasopharyngeal Carcinoma, run by Chinese University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- transoral flexible endoscope with magnifying narrow band imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Study to Evaluate the Use of a Transoral Flexible Endoscope With Magnifying Narrow Band Imaging in Nasopharyngeal Cancer
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.
Read more
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?
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- transoral flexible endoscope with magnifying narrow band imaging
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transoral flexible endoscope with magnifying narrow band imagingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| esophago-gastroscopy endoscopy with narrow band imaging | Other | a transoral flexible endoscope with magnifying narrow band imaging in nasopharyngeal examination Receives: Device: transoral flexible endoscope with magnifying narrow band imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The vasculature of the nasopharyngeal region
The vasculature of the nasopharyngeal region which capture by the transoral flexible endoscope with magnifying narrow band imaging
Measured: during enrollment period
Secondary outcomes (1)
Histological features of nasopharyngeal lesion
Histological features of nasopharyngeal biopsy which is done during endoscopy with magnifying narrow band imaging.
Measured: during enrollment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a case-control pilot study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Chan, Chinese University of Hong Kong
- Investigators
- Jason Chan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419324
- Sponsor's protocol ID
- 01
- Status last verified
- Jun 2020
- First submitted
- 31 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Use of a Transoral Flexible Endoscope With Magnifying Narrow Band Imaging in Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT04419324
- Acronym / sponsor ID
- 01
- Conditions
- Nasopharyngeal Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a case-control pilot study
| Arm | Type | Receives |
|---|---|---|
| esophago-gastroscopy endoscopy with narrow band imaging | Other | Device: transoral flexible endoscope with magnifying narrow band imaginga transoral flexible endoscope with magnifying narrow band imaging in nasopharyngeal examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transoral flexible endoscope with magnifying narrow band imagingTo 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. | Device | esophago-gastroscopy endoscopy with narrow band imaging |
Primary outcome
The vasculature of the nasopharyngeal region
Time frame: during enrollment period
The vasculature of the nasopharyngeal region which capture by the transoral flexible endoscope with magnifying narrow band imaging
1 secondary outcome
Histological features of nasopharyngeal lesion
Time frame: during enrollment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Chan principal investigator
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing transoral flexible endoscope with magnifying narrow band imaging in people with Nasopharyngeal Carcinoma, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cherrie NG (+852 35051409, cherrieng@ent.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The vasculature of the nasopharyngeal region (time frame: during enrollment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.