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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03202173
• Other study ID #: pCLE in the diagnosis of NPC
• Status: Recruiting
• Phase: N/A
• First received: June 27, 2017
• Last updated: January 31, 2018
• Start date: January 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2018
• Source: Eye & ENT Hospital of Fudan University
• Contact: Huawei Li, Phd &MD
• Email: hwli[@]shmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: June 30, 2018
• Est. primary completion date: December 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Diagnostic Test:
• 10% fluorescein
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.

Locations

Country	Name	City	State
China	Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCLE classification and scoring system	Evaluation of pCLE diagnostic performance for the diagnosis of NPC when associated with other diagnostic information.	3 months
Secondary	the quantitative image analysis	Quantitative image features are calculated in the pCLE images	3 months