NCT03202173

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

12 months

First QC Date

June 27, 2017

Last Update Submit

January 31, 2018

Conditions

Nasopharyngeal CarcinomaSquamous Cell Carcinoma of the Head and Neck

Keywords

Probe-based confocal laser endomicroscopyOptical biopsy

Outcome Measures

Primary Outcomes (1)

  • pCLE classification and scoring system

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

    3 months

Secondary Outcomes (1)

  • the quantitative image analysis

    3 months

Study Arms (3)

normal mucosa

ACTIVE COMPARATOR

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.

Diagnostic Test: 10% fluorescein

lymphoid hyperplasia

EXPERIMENTAL

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..

Diagnostic Test: 10% fluorescein

nasopharyngeal carcinoma

EXPERIMENTAL

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.

Diagnostic Test: 10% fluorescein

Interventions

10% fluoresceinDIAGNOSTIC_TEST

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.

lymphoid hyperplasianasopharyngeal carcinomanormal mucosa

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal CarcinomaSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesCarcinoma, Squamous Cell

Study Officials

  • Huawei Li, Phd &MD

    Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University

    STUDY CHAIR

Central Study Contacts

Huawei Li, Phd &MD

CONTACT

hwli@shmu.edu.cn

Lingjie Wu, MS & MD

CONTACT

wulingjie116@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University

Study Record Dates

First Submitted

June 27, 2017

First Posted

June 28, 2017

Study Start

January 1, 2017

Primary Completion

December 27, 2017

Study Completion

June 30, 2018

Last Updated

February 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)