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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Diagnosis of the Squamous Cell Carcinoma in Head and Neck by Using the Probe-based Confocal Laser Endomicroscopy

Conditions
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Nasopharyngeal Carcinoma, Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
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* Diagnostic Test: 10% fluorescein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female > 18 years of age Indicated for nasal endoscope for indeterminate NPC Willing and able to comply with study procedures and provide written informed consent to participate in the study Exclusion Criteria: Subjects for whom pCLE procedures are contraindicated Known allergy to fluorescein dye If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: normal mucosa<br>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. | Diagnostic Test: 10% fluorescein<br>* The nasopharyngeal lesions were first identified endoscopically by nasal endoscope. Then, an initial dose of 0.5 mL prior to the examination with a maximum dose of 2.5 mL of 10% fluorescein (IV; Akorn Inc, Lake Forest, Illinois, USA) during the measurement procedure was defined according to the experiences of workgroup in the gastrointestinal tract.<br>|
| Experimental: lymphoid hyperplasia<br>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.. | Diagnostic Test: 10% fluorescein<br>* The nasopharyngeal lesions were first identified endoscopically by nasal endoscope. Then, an initial dose of 0.5 mL prior to the examination with a maximum dose of 2.5 mL of 10% fluorescein (IV; Akorn Inc, Lake Forest, Illinois, USA) during the measurement procedure was defined according to the experiences of workgroup in the gastrointestinal tract.<br>|
| Experimental: nasopharyngeal carcinoma<br>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. | Diagnostic Test: 10% fluorescein<br>* The nasopharyngeal lesions were first identified endoscopically by nasal endoscope. Then, an initial dose of 0.5 mL prior to the examination with a maximum dose of 2.5 mL of 10% fluorescein (IV; Akorn Inc, Lake Forest, Illinois, USA) during the measurement procedure was defined according to the experiences of workgroup in the gastrointestinal tract.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCLE classification and scoring system | Evaluation of pCLE diagnostic performance for the diagnosis of NPC when associated with other diagnostic information. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the quantitative image analysis | Quantitative image features are calculated in the pCLE images | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probe-based confocal laser endomicroscopy, Optical biopsy