- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03202173
The Diagnosis of NPC Using the Probe-based Confocal Laser Endomicroscopy
January 31, 2018 updated by: Huawei Li, Ph.D, MD, Eye & ENT Hospital of Fudan University
The Diagnosis of the Squamous Cell Carcinoma in Head and Neck by Using the Probe-based Confocal Laser Endomicroscopy
To evaluate the use of probe-based confocal laser endomicroscopy (pCLE) in human nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas.
Study Overview
Status
Unknown
Intervention / Treatment
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
Enrollment (Anticipated)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huawei Li, Phd &MD
- Email: hwli@shmu.edu.cn
Study Contact Backup
- Name: Lingjie Wu, MS & MD
- Email: wulingjie116@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200031
- Recruiting
- Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
-
Contact:
- Huawei Li, Phd &MD
- Email: hwli@shmu.edu.cn
-
Principal Investigator:
- Huawei Li, Phd & MD
-
Sub-Investigator:
- Yusu Ni, Phd & MD
-
Principal Investigator:
- Wenyan Li, Phd & MD
-
Sub-Investigator:
- Yunfeng Wang, Phd & MD
-
Principal Investigator:
- Lingjie Wu, MS & MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: normal mucosa
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.
|
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.
|
Experimental: lymphoid hyperplasia
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..
|
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.
|
Experimental: nasopharyngeal carcinoma
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pCLE classification and scoring system
Time Frame: 3 months
|
Evaluation of pCLE diagnostic performance for the diagnosis of NPC when associated with other diagnostic information.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the quantitative image analysis
Time Frame: 3 months
|
Quantitative image features are calculated in the pCLE images
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Huawei Li, Phd &MD, Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
December 27, 2017
Study Completion (Anticipated)
June 30, 2018
Study Registration Dates
First Submitted
June 27, 2017
First Submitted That Met QC Criteria
June 27, 2017
First Posted (Actual)
June 28, 2017
Study Record Updates
Last Update Posted (Actual)
February 5, 2018
Last Update Submitted That Met QC Criteria
January 31, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Neoplasms, Squamous Cell
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
Other Study ID Numbers
- pCLE in the diagnosis of NPC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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