The Diagnosis of NPC Using the Probe-based Confocal Laser Endomicroscopy
NCT ID: NCT03202173
Last Updated: 2018-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
31 participants
INTERVENTIONAL
2017-01-01
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
TRIPLE
Study Groups
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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.
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.
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..
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
85 Years
ALL
No
Sponsors
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Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Huawei Li, Ph.D, MD
Director of Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
Principal Investigators
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Huawei Li, Phd &MD
Role: STUDY_CHAIR
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
Locations
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Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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pCLE in the diagnosis of NPC
Identifier Type: -
Identifier Source: org_study_id
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