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

Primary Purpose

Nasopharyngeal Carcinoma, Squamous Cell Carcinoma of the Head and Neck

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

10% fluorescein

About this trial

This is an interventional diagnostic trial for Nasopharyngeal Carcinoma focused on measuring Probe-based confocal laser endomicroscopy, Optical biopsy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

normal mucosa

lymphoid hyperplasia

nasopharyngeal carcinoma

Arm 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.

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..

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.

Outcomes

Primary Outcome Measures

pCLE classification and scoring system

Evaluation of pCLE diagnostic performance for the diagnosis of NPC when associated with other diagnostic information.

Secondary Outcome Measures

the quantitative image analysis

Quantitative image features are calculated in the pCLE images

Full Information

NCT ID

NCT03202173

First Posted

June 27, 2017

Last Updated

January 31, 2018

Sponsor

Eye & ENT Hospital of Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03202173

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

December 27, 2017 (Actual)

Study Completion Date

June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Eye & ENT Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma, Squamous Cell Carcinoma of the Head and Neck

Keywords

Probe-based confocal laser endomicroscopy, Optical biopsy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Non-Randomized

Enrollment

31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

normal mucosa

Arm Type

Active Comparator

Arm 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.

Arm Title

lymphoid hyperplasia

Arm Type

Experimental

Arm Description

Arm Title

nasopharyngeal carcinoma

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

10% fluorescein

Intervention Description

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.

Primary Outcome Measure Information:

Title

pCLE classification and scoring system

Description

Evaluation of pCLE diagnostic performance for the diagnosis of NPC when associated with other diagnostic information.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

the quantitative image analysis

Description

Quantitative image features are calculated in the pCLE images

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huawei Li, Phd &MD

hwli@shmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Lingjie Wu, MS & MD

wulingjie116@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huawei Li, Phd &MD

Organizational Affiliation

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University

Official's Role

Study Chair

Facility Information:

Facility Name

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200031

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huawei Li, Phd &MD

hwli@shmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Lingjie Wu, MS &MD

wulingjie116@163.com

First Name & Middle Initial & Last Name & Degree

Yusu Ni, Phd & MD

First Name & Middle Initial & Last Name & Degree

Wenyan Li, Phd & MD

First Name & Middle Initial & Last Name & Degree

Yunfeng Wang, Phd & MD

First Name & Middle Initial & Last Name & Degree

Lingjie Wu, MS & MD

First Name & Middle Initial & Last Name & Degree

Huawei Li, Phd & MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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