Brief Title
The Diagnosis of NPC Using the Probe-based Confocal Laser Endomicroscopy
Official Title
The Diagnosis of the Squamous Cell Carcinoma in Head and Neck by Using the Probe-based Confocal Laser Endomicroscopy
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 Type
Interventional
Primary Outcome
pCLE classification and scoring system
Secondary Outcome
the quantitative image analysis
Condition
Nasopharyngeal Carcinoma
Intervention
10% fluorescein
Study Arms / Comparison Groups
normal mucosa
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
31
Start Date
January 1, 2017
Completion Date
June 30, 2018
Primary Completion Date
December 27, 2017
Eligibility Criteria
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
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Huawei Li, Phd &MD, , [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03202173
Organization ID
pCLE in the diagnosis of NPC
Responsible Party
Principal Investigator
Study Sponsor
Eye & ENT Hospital of Fudan University
Study Sponsor
Huawei Li, Phd &MD, Study Chair, Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
Verification Date
January 2018