The Diagnosis of NPC Using the Probe-based Confocal Laser Endomicroscopy

Not Applicable

• Conditions: Squamous Cell Carcinoma of the Head and Neck; Nasopharyngeal Carcinoma
• Interventions: Diagnostic Test: 10% fluorescein

• Registration Number: NCT03202173
• Lead Sponsor: Eye & ENT Hospital of Fudan University

Brief Summary

To evaluate the use of probe-based confocal laser endomicroscopy (pCLE) in human nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas.

Detailed Description

The aim of this study was to depict the applicability of pCLE examinations for diagnosing NPC in comparison to the gold standard of histopathological examination, as well as developed an easy-to-use and straightforward scoring system for the identification of NPC on the basis of morphological and architectural criteria in order to enable a valid and reproducible CLE assessment even for non-experts in their daily clinical practice.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Primary Completion: 2017-12-27
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-05
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Male or female > 18 years of age
2. Indicated for nasal endoscope for indeterminate NPC
3. Willing and able to comply with study procedures and provide written informed consent to participate in the study

Exclusion Criteria

1. Subjects for whom pCLE procedures are contraindicated
2. Known allergy to fluorescein dye
3. If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
normal mucosa	10% fluorescein	Flat and relatively uniform polygonal epithelial cells with alternating dark and light bands were noted in pCLE images of normal mucosa after intravenous injecting 10% fluorescein.
lymphoid hyperplasia	10% fluorescein	An unorganized tissue architecture, irregular cells (difference of cell shape, color and size), slightly intensified fluorescein leakage, and vessels not assessable were found in the lymphoid hyperplasia of nasopharyngeal mucosa after intravenous injecting 10% fluorescein..
nasopharyngeal carcinoma	10% fluorescein	pCLE images of nasopharyngeal carcinoma, which was associated with crowded unorganized tissue architecture (a dark-gray background without identification of mucosal structures), irregular cells like cell clusters, amplified fluorescein leakage, and irregular vessels changes after intravenous injecting 10% fluorescein.

Primary Outcome Measures

Name	Time	Method
pCLE classification and scoring system	3 months	Evaluation of pCLE diagnostic performance for the diagnosis of NPC when associated with other diagnostic information.

Secondary Outcome Measures

Name	Time	Method
the quantitative image analysis	3 months	Quantitative image features are calculated in the pCLE images

Trial Locations

Locations (1)

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China; 🇨🇳 Shanghai, Shanghai, China