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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03202173

Enrollment

Registered

2017-06-28

Start date

2017-01-01

Completion date

2018-06-30

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma, Squamous Cell Carcinoma of the Head and Neck

Keywords

Probe-based confocal laser endomicroscopy, Optical biopsy

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.

Interventions

DIAGNOSTIC_TEST10% 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
the quantitative image analysis	3 months	Quantitative image features are calculated in the pCLE images

Countries

China

Contacts

Primary ContactHuawei Li, Phd &MD

hwli@shmu.edu.cn

Backup ContactLingjie Wu, MS & MD

wulingjie116@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026