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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Hon Chi Yip, MBChB, FRCSEd contact

35052956

hcyip@surgery.cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • Prince of Wales Hospital

    Hong Kong

    Hon Chi YIP, FRCSEd, 35052627, hcyip@surgery.cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

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.

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 groups in NCT04593186
Study groupRoleWhat they receive
Trans-oral magnifying endoscopy with NBIExperimentalTransoral 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.

  1. Rate of Newly diagnosed Nasopharyngeal cancer

    Newly diagnosed nasopharyngeal cancer with the novel endoscopic approach

    Measured: 1 month

Secondary outcomes (7)
  1. Rate of Adverse event - overall

    Rate of Adverse event related to the endoscopic procedure

    Measured: 7 days

  2. Rate of adverse event - haemorrhage

    Rate of haemorrhage related to the endoscopic procedure

    Measured: 7 days

  3. Rate of adverse event - perforation

    Rate of perforation related to the endoscopic procedure

    Measured: 7 days

  4. Rate of adverse event - infection

    Rate of infection related to the endoscopic procedure

    Measured: 7 days

  5. Rate of adverse event - aspiration pneumonia

    Rate of aspiration pneumonia related to the endoscopic procedure

    Measured: 7 days

  6. Stage of the newly diagnosed nasopharyngeal cancer

    TNM stage distribution of the newly diagnosed NPC

    Measured: 1 month

  7. 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.

  1. First posted19 Oct 2020
  2. Study start15 Apr 2021
  3. Primary completion31 Oct 2023 (estimated)
  4. Study completion30 Nov 2024 (estimated)

Resources

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)
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

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.

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