NBI to Detect Post-RT Mucosal Residual NPC

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

Study Overview

• Status: Completed
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Device: Laryngoscope with NBI system

Detailed Description

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

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

Method:

1. All newly biopsy confirmed NPC patient will be assessed, their nasopharynx endoscopic image will be captured using both WL + NBI system
2. 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

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Pamela Youde Nethersole Eastern Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Post radiotherapy 8 weeks NPC patient; 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

Device: Laryngoscope with NBI system; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient	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	Post-radiotherapy 8th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group	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.	Post-radiotherapy eight weeks
The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern	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.	Post-radiotherapy eight weeks

Collaborators and Investigators

• Sponsor: Pamela Youde Nethersole Eastern Hospital
• Investigators: Principal Investigator: Wong Kai Chuen, MBChB, MRCS, Pamela Youde Nethersole Eastern Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: October 21, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Nasopharyngeal carcinoma; Narrow band imaging
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: NBI1782015