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

Eye & ENT Hospital of Fudan University

Status: Unknown

Conditions: Squamous Cell Carcinoma of the Head and Neck; Nasopharyngeal Carcinoma

Treatments: Diagnostic Test: 10% fluorescein

Study type: Interventional

Funder types: Other

Identifiers

NCT03202173

pCLE in the diagnosis of NPC

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

31 participants in 3 patient groups

normal mucosa

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: 10% fluorescein

lymphoid hyperplasia

Experimental group

Description:

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..

Treatment:

Diagnostic Test: 10% fluorescein

nasopharyngeal carcinoma

Experimental group

Description:

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.

Treatment:

Diagnostic Test: 10% fluorescein