Nasopharyngeal CarcinomaNCT04593186
Magnifying NBI for Occult NPC
A study testing Trans-oral magnifying endoscopy with NBI in people with Nasopharyngeal Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Diagnosis of nasopharyngeal carcinoma (NPC) is currently made by trans-nasal endoscopy and biopsy. The small caliber endoscope provides only a limited view of the nasopharynx and may not be able to provide a thorough assessment of the nasopharynx. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Trans-oral magnifying endoscopy with NBI
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Apr 2021to 30 Nov 2024
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, age ≥ 18 years old
- Positive result on plasma EBV-DNA analysis
- No cancer identified on conventional investigations including nasoendoscopy and MRI
Who cannot join
- History of nasopharyngeal, oropharyngeal cancer
- Patients on anticoagulation (Including warfarin and other direct oral anti-coagulants)
- Bleeding tendency (International Normalized Ratio (INR) > 1.5 or Platelet < 50 x109/L)
- Trismus, unable to pass oral endoscope
- Allergic to local anaesthetic agents (Lignocaine)
- Failure of vital organ (heart, lungs, liver, or kidneys) function
- Other conditions deemed unsuitable for endoscopy
- Refusal to participate, or inability to sign consent for study
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Hon Chi YIP, FRCSEd, 35052627, hcyip@surgery.cuhk.edu.hk
About this study
Official title: Trans-oral Magnifying Endoscopy With Narrow Band Imaging for Screening of Nasopharyngeal Carcinoma
Diagnosis of nasopharyngeal carcinoma (NPC) is currently made by trans-nasal endoscopy and biopsy. The small caliber endoscope provides only a limited view of the nasopharynx and may not be able to provide a thorough assessment of the nasopharynx. The investigators have developed a novel endoscopic approach to access the nasopharynx by using a trans-oral high definition endoscope with magnification and image enhancement function. In this cohort study, we aim to investigate the efficacy of diagnosing NPC by applying the novel technique in a high risk patient group with elevated plasma EBV DNA but with negative screening with conventional trans-nasal endoscopy.
Read the detailed description
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).
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 success. Researchers at Chinese University of Hong Kong 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 nasoendoscopes1. Flexible endoscopy using conventional esophago-gastroscopy endoscope (OGD) with NBI and magnification power up to 80x overcome the limitations of current nasoendoscopes. The passage of the endoscope through the mouth and retroflexion at oropharynx could visualize the nasopharynx clearly and detailed assessment is feasible.
Here in this study the investigators will seek to use a trans-oral magnifying endoscopy with NBI and retroflexion into the nasopharynx to view the nasopharynx to evaluate the feasibility in the diagnosis of occult nasopharyngeal carcinoma.
The aim of this study is to investigate the clinical usefulness of trans-oral magnifying endoscopy with NBI as a screening tool for patients at increased risk of nasopharyngeal carcinoma (NPC).
The investigators hypothesize that with the use of magnifying NBI trans-oral endoscopy, the nasopharynx could improve the diagnostic yield of NPC in high risk patients with negative test on conventional investigations. As a result, such endoscopic screening tool could be used routinely to identify early NPC in patients deemed at risk.
Study Design
This study is a prospective single arm study designed to evaluate the diagnostic yield of trans-oral magnifying NBI endoscopic assessment of nasopharynx in patients who are deemed elevated risk of NPC but with negative traditional endoscopic and radiological screening.
In a previous study conducted by the Department of Chemical Pathology and Otorhinolaryngology, screening of 20000 asymptomatic individuals was performed using plasma Epstein Barr Virus DNA analysis. The presence of plasma EBV DNA consisting of short DNA fragments released by NPC cells helped identify NPC patients. In the published results, 34 NPC was identified in 300-screened positive individuals. In the rest of the cohort, NPC was not identified with initial nasoendoscopy and biopsy. A few more cancers was subsequently identified on Magnetic Resonance Imaging upon follow-up at 3 years and was confirmed with repeated endoscopic biopsies. In the current study the investigators would invite patients with persistently positive screening on plasma EBV-DNA analysis and no cancer found on usual diagnostic tests to undergo the novel screening endoscopy.
Individuals would be screened for eligibility at the clinic follow-up at the Department of Otorhinolaryngology. Study consent would be taken if they agree to participate in the current study.
Endoscopic procedures would be performed by endoscopists with expertise on performing magnifying NBI endoscopy at the Combined Endoscopy Center, Prince of Wales Hospital. It would be conducted at the Combined Endoscopy Center, Prince of Wales Hospital. Topical local anaesthetic will be applied to the oropharynx and nasopharynx. In addition, intravenous sedation by use of Midazolam and Fentanyl would be given. 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. Biopsy would be taken if suspicious lesion is identified during the procedure.
In addition, non-contrast Magnetic Resonance Imaging (MRI) of the nasopharynx would be performed if the participants have not received a similar scan in recent 6 months and have no contra-indications to MRI. The MRI finding would be correlated with the endoscopic and histological findings.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Trans-oral magnifying endoscopy with NBI
- Keywords
- nasopharyngeal carcinoma, Narrow band Imaging, Magnifying endoscopy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-oral magnifying endoscopy with NBIProcedure or surgery
Endoscopic procedures would be performed by endoscopists with expertise on performing magnifying NBI endoscopy. Topical local anaesthetic will be applied to the oropharynx and nasopharynx. In addition, intravenous sedation by use of Midazolam and Fentanyl would be given. 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. Biopsy would be taken if suspicious lesion is identified during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Trans-oral magnifying endoscopy with NBI | Experimental | Transoral magnifying endoscopy with High Definition Upper Endoscope with Narrow Band Imaging enhancement (Olympus GIF-H290Z) Receives: Procedure: Trans-oral magnifying endoscopy with NBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Newly diagnosed Nasopharyngeal cancer
Newly diagnosed nasopharyngeal cancer with the novel endoscopic approach
Measured: 1 month
Secondary outcomes (7)
Rate of Adverse event - overall
Rate of Adverse event related to the endoscopic procedure
Measured: 7 days
Rate of adverse event - haemorrhage
Rate of haemorrhage related to the endoscopic procedure
Measured: 7 days
Rate of adverse event - perforation
Rate of perforation related to the endoscopic procedure
Measured: 7 days
Rate of adverse event - infection
Rate of infection related to the endoscopic procedure
Measured: 7 days
Rate of adverse event - aspiration pneumonia
Rate of aspiration pneumonia related to the endoscopic procedure
Measured: 7 days
Stage of the newly diagnosed nasopharyngeal cancer
TNM stage distribution of the newly diagnosed NPC
Measured: 1 month
Duration of the endoscopic procedure
Duration from scope insertion to scope withdrawal
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Apr 2021
- Primary completion31 Oct 2023 (estimated)
- Study completion30 Nov 2024 (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
- Trans-oral magnifying endoscopy with Narrow Band Imaging assessment of nasopharynx
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon Chi Yip, Chinese University of Hong Kong
- Investigators
- Hon Chi Yip, MBChB, FRCSEd, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593186
- Sponsor's protocol ID
- CRE-2020.426
- Status last verified
- Sep 2023
- First submitted
- 13 Oct 2020
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- 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 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-oral Magnifying Endoscopy With Narrow Band Imaging for Screening of Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04593186
- Acronym / sponsor ID
- CRE-2020.426
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- nasopharyngeal carcinoma, Narrow band Imaging, Magnifying endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 19 Oct 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.
Diagnosis of nasopharyngeal carcinoma (NPC) is currently made by trans-nasal endoscopy and biopsy. The small caliber endoscope provides only a limited view of the nasopharynx and may not be able to provide a thorough assessment of the nasopharynx. The investigators have developed a novel endoscopic approach to access the nasopharynx by using a trans-oral high definition endoscope with magnification and image enhancement function. In this cohort study, we aim to investigate the efficacy of diagnosing NPC by applying the novel technique in a high risk patient group with elevated plasma EBV DNA but with negative screening with conventional trans-nasal endoscopy.
Detailed description
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).
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 success. Researchers at Chinese University of Hong Kong 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 nasoendoscopes1. Flexible endoscopy using conventional esophago-gastroscopy endoscope (OGD) with NBI and magnification power up to 80x overcome the limitations of current nasoendoscopes. The passage of the endoscope through the mouth and retroflexion at oropharynx could visualize the nasopharynx clearly and detailed assessment is feasible.
Here in this study the investigators will seek to use a trans-oral magnifying endoscopy with NBI and retroflexion into the nasopharynx to view the nasopharynx to evaluate the feasibility in the diagnosis of occult nasopharyngeal carcinoma.
The aim of this study is to investigate the clinical usefulness of trans-oral magnifying endoscopy with NBI as a screening tool for patients at increased risk of nasopharyngeal carcinoma (NPC).
The investigators hypothesize that with the use of magnifying NBI trans-oral endoscopy, the nasopharynx could improve the diagnostic yield of NPC in high risk patients with negative test on conventional investigations. As a result, such endoscopic screening tool could be used routinely to identify early NPC in patients deemed at risk.
Study Design
This study is a prospective single arm study designed to evaluate the diagnostic yield of trans-oral magnifying NBI endoscopic assessment of nasopharynx in patients who are deemed elevated risk of NPC but with negative traditional endoscopic and radiological screening.
In a previous study conducted by the Department of Chemical Pathology and Otorhinolaryngology, screening of 20000 asymptomatic individuals was performed using plasma Epstein Barr Virus DNA analysis. The presence of plasma EBV DNA consisting of short DNA fragments released by NPC cells helped identify NPC patients. In the published results, 34 NPC was identified in 300-screened positive individuals. In the rest of the cohort, NPC was not identified with initial nasoendoscopy and biopsy. A few more cancers was subsequently identified on Magnetic Resonance Imaging upon follow-up at 3 years and was confirmed with repeated endoscopic biopsies. In the current study the investigators would invite patients with persistently positive screening on plasma EBV-DNA analysis and no cancer found on usual diagnostic tests to undergo the novel screening endoscopy.
Individuals would be screened for eligibility at the clinic follow-up at the Department of Otorhinolaryngology. Study consent would be taken if they agree to participate in the current study.
Endoscopic procedures would be performed by endoscopists with expertise on performing magnifying NBI endoscopy at the Combined Endoscopy Center, Prince of Wales Hospital. It would be conducted at the Combined Endoscopy Center, Prince of Wales Hospital. Topical local anaesthetic will be applied to the oropharynx and nasopharynx. In addition, intravenous sedation by use of Midazolam and Fentanyl would be given. 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. Biopsy would be taken if suspicious lesion is identified during the procedure.
In addition, non-contrast Magnetic Resonance Imaging (MRI) of the nasopharynx would be performed if the participants have not received a similar scan in recent 6 months and have no contra-indications to MRI. The MRI finding would be correlated with the endoscopic and histological findings.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Trans-oral magnifying endoscopy with Narrow Band Imaging assessment of nasopharynx
| Arm | Type | Receives |
|---|---|---|
| Trans-oral magnifying endoscopy with NBI | Experimental | Procedure: Trans-oral magnifying endoscopy with NBITransoral magnifying endoscopy with High Definition Upper Endoscope with Narrow Band Imaging enhancement (Olympus GIF-H290Z) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male, age ≥ 18 years old
- Positive result on plasma EBV-DNA analysis
- No cancer identified on conventional investigations including nasoendoscopy and MRI
Key exclusion criteria (8 listed)
- History of nasopharyngeal, oropharyngeal cancer
- Patients on anticoagulation (Including warfarin and other direct oral anti-coagulants)
- Bleeding tendency (International Normalized Ratio (INR) > 1.5 or Platelet < 50 x109/L)
- Trismus, unable to pass oral endoscope
- Allergic to local anaesthetic agents (Lignocaine)
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 |
|---|---|---|
| Trans-oral magnifying endoscopy with NBIEndoscopic procedures would be performed by endoscopists with expertise on performing magnifying NBI endoscopy. Topical local anaesthetic will be applied to the oropharynx and nasopharynx. In addition, intravenous sedation by use of Midazolam and Fentanyl would be given. 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. Biopsy would be taken if suspicious lesion is identified during the procedure. | Procedure or surgery | Trans-oral magnifying endoscopy with NBI |
Primary outcome
Rate of Newly diagnosed Nasopharyngeal cancer
Time frame: 1 month
Newly diagnosed nasopharyngeal cancer with the novel endoscopic approach
7 secondary outcomes
Rate of Adverse event - overall
Time frame: 7 days
Rate of adverse event - haemorrhage
Time frame: 7 days
Rate of adverse event - perforation
Time frame: 7 days
Rate of adverse event - infection
Time frame: 7 days
Rate of adverse event - aspiration pneumonia
Time frame: 7 days
Stage of the newly diagnosed nasopharyngeal cancer
Time frame: 1 month
Duration of the endoscopic procedure
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- 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.
Hon Chi Yip, MBChB, FRCSEd principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-oral magnifying endoscopy with NBI in people with Nasopharyngeal Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hon Chi Yip, MBChB, FRCSEd (35052956, hcyip@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Newly diagnosed Nasopharyngeal cancer (time frame: 1 month). 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 7 Sep 2023.