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NCT Number: NCT02584790

NBI to Detect Post-RT Mucosal Residual NPC

NBI has been proven to be a useful tool to detect early NPC, but they were few studies concerning the detection of post-radiotherapy mucosal residual NPC using NBI system

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamela Youde Nethersole Eastern Hospital

Hong Kong

About this study

Background

NPC has a uniquely high prevalence in Southern China. According to the Hong Kong Cancer Registry in 2012, NPC was the sixth commonest cancer in men and thirteenth in women. It accounted for 2.9% of all new cancer cases. In 2012, there were 819 new cases of NPC.

NPC is highly radiosensitive. Radiotherapy and chemotherapy are the mainstay of treatment. Despite the chemo-irradiation, disease control failure still occurred in NPC patients presenting as persistent tumor. Early detection of those post-radiotherapy residual NPC is essential for early arrangement of salvage therapy. Detection methods include imaging, plasma Epstein-Barr virus DNA, endoscopy examinations and nasopharynx biopsy.

NBI system has been well proven as a tool to detect early digestive tract cancer and head and neck cancer. However, there were only few studies targeting the detection of post-radiotherapy mucosal residual of NPC using NBI system

Objective

  • To identify the vessel pattern of those confirmed NPC case using NBI system
  • To identify the endoscopy features of post-radiotherapy mucosal residual nasopharyngeal carcinoma using NBI system
  • To establish the positive predicted value, negative predicted value, sensitivity and specificity of using NBI system for detecting mucosal residual NPC

Method:

  • All newly biopsy confirmed NPC patient will be assessed, their nasopharynx endoscopic image will be captured using both WL + NBI system
  • At post-radiotherapy 8th weeks, endoscopic examination will be arranged for patient using both WL + NBI system, biopsy will also be taken to detect mucosal residual NPC

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all new NPC patient

Exclusion criteria

  • History of radiotherapy to head and neck region
  • Poor premorbid status/ non-communicable patients
  • <18 years old
  • Pregnancy

Treatment and study plan

Laryngoscope with NBI system

Device

All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system

Primary outcomes

  1. Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient

    Time frame: Post-radiotherapy 8th week

    4 grading of NBI vessel patterns can be identified in those post-radiotherapy 8 weeks NPC patients.

    Grade A: normal vessel size and length, regular pattern Grade B: normal vessel size, short, regular spiderweb like pattern Grade C: irregular vessel size and length, distorted and irregular pattern Grade D: thickened vessel size, elongated, distorted, and earthworm pattern

Secondary outcomes

  1. Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group

    Time frame: Post-radiotherapy eight weeks

    Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D

    The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated.

  2. The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern

    Time frame: Post-radiotherapy eight weeks

    Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D

    The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated.

Sponsors and collaborators

Lead sponsor

Pamela Youde Nethersole Eastern Hospital

Other

Registry information

Official study title

Using Narrow-band Imaging (NBI) Technique to Detect Post-radiotherapy Mucosal Residual Nasopharyngeal Carcinoma (NPC)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 23, 2015
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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