New endoscopic technique for diagnosing nasopharyngeal carcinoma
Trans-oral Magnifying Endoscopy With Narrow Band Imaging for Screening of Nasopharyngeal Carcinoma
This study is testing a new endoscopic method to see if it can help doctors better diagnose nasopharyngeal cancer in patients who have high levels of EBV DNA but had negative results from regular endoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 246 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04593186 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel trans-oral high definition endoscopic approach using magnifying narrow band imaging (NBI) to improve the diagnosis of nasopharyngeal carcinoma (NPC) in patients with elevated plasma EBV DNA but negative results from conventional endoscopy. The aim is to enhance visualization of the nasopharynx, allowing for better identification of lesions that may be missed with traditional methods. By utilizing advanced imaging techniques, the study seeks to reduce unnecessary biopsies and improve diagnostic accuracy in a high-risk patient population.
Who should consider this trial
Good fit: Ideal candidates include males aged 18 and older with positive plasma EBV-DNA results and no cancer detected through conventional investigations.
Not a fit: Patients with a history of nasopharyngeal or oropharyngeal cancer or those with bleeding tendencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnosis of nasopharyngeal carcinoma, potentially improving patient outcomes.
How similar studies have performed: While there have been studies using NBI for NPC diagnosis, this specific approach with magnifying endoscopy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male, age ≥ 18 years old 2. Positive result on plasma EBV-DNA analysis 3. No cancer identified on conventional investigations including nasoendoscopy and MRI Exclusion Criteria: 1. History of nasopharyngeal, oropharyngeal cancer 2. Patients on anticoagulation (Including warfarin and other direct oral anti-coagulants) 3. Bleeding tendency (International Normalized Ratio (INR) \> 1.5 or Platelet \< 50 x109/L) 4. Trismus, unable to pass oral endoscope 5. Allergic to local anaesthetic agents (Lignocaine) 6. Failure of vital organ (heart, lungs, liver, or kidneys) function 7. Other conditions deemed unsuitable for endoscopy 8. Refusal to participate, or inability to sign consent for study
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Hon Chi Yip, MBChB, FRCSEd — Chinese University of Hong Kong
- Study coordinator: Hon Chi Yip, MBChB, FRCSEd
- Email: hcyip@surgery.cuhk.edu.hk
- Phone: 35052956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.