Diagnosis of Laryngeal Lesions Using the Probe-based Confocal Laser Endomicroscopy

The Diagnosis of Laryngeal Lesions Using the Probe-based Confocal Laser Endomicroscopy in Vivo

To evaluate the diagnosis of laryngeal lesions using the Probe-based Confocal Laser Endomicroscopy in vivo.

Study Overview

• Status: Unknown
• Conditions: Laryngeal Leiomyoma; Probe-based Confocal Laser Endomicroscopy
• Intervention / Treatment: Diagnostic test: Confocal Laser Endomicroscopy

Detailed Description

In this study, we will conduct in-vivo confocal laser endoscopic imaging studies of laryngeal and precancerous lesions to explore the value of pCLE in the diagnosis of laryngeal cancers.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Lingjie Wu, PhD &MD; Phone Number: +86-15821574627; Email: wulingjie116@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
      • Contact: Lingjie Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with suspicious unidentified lesions were collected in this study in Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, who need to be underwent microscopic laryngoscopy.

Description

Inclusion Criteria:

1. 18≤Male or female age ≤85 years old;
2. patients with vocal cord lesions founded by white light laryngoscope and needed to perform laryngeal microsurgery;
3. Willing and able to comply with study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Male or female <18 years old, or Male or female >85 years;
2. The patient has abnormal blood or coagulation function, and there is a risk of bleeding during the examination;
3. The patient has severe cardiopulmonary function or liver and kidney dysfunction and cannot tolerate surgery.
4. The patient has a history of allergies to drugs or food.
5. The patient has a positive serotonin sodium allergy test and is allergic to sodium fluorescein;
6. Lactation or pregnant women.
7. Refusal to sign the informed consent form.
8. Others who do not take this test.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Confocal Laser Endomicroscopy; Confocal laser microendoscopy (CLE) as a new non-invasive imaging technique can be used for "optical biopsy", which can perform real-time microscopic information of tissue in vivo at cellular level with resolutions up to 1μm and magnifications up to 1000 times. CLE is now being increasingly used with very promising results in gastroenterology, especially in the diagnostic investigation of Barret's esophagus, stomach cancer, colorectal cancer and various lesions of the biliary tract. With an intravenous injection of fluorescein, probe-based CLE (pCLE: GastroFlex probe with the Cellvizio laser system, Mauna Technologies, Paris, France) allows us to view the interstitial spaces, cells, and small capillaries in a window of 240 μm and to a depth of 60 μm.
non-malignant lesions; 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 non-malignant lesions after intravenous injecting 10% fluorescein.	Diagnostic test: Confocal Laser Endomicroscopy; Confocal laser microendoscopy (CLE) as a new non-invasive imaging technique can be used for "optical biopsy", which can perform real-time microscopic information of tissue in vivo at cellular level with resolutions up to 1μm and magnifications up to 1000 times. CLE is now being increasingly used with very promising results in gastroenterology, especially in the diagnostic investigation of Barret's esophagus, stomach cancer, colorectal cancer and various lesions of the biliary tract. With an intravenous injection of fluorescein, probe-based CLE (pCLE: GastroFlex probe with the Cellvizio laser system, Mauna Technologies, Paris, France) allows us to view the interstitial spaces, cells, and small capillaries in a window of 240 μm and to a depth of 60 μm.
malignant lesions; pCLE images of malignant lesions were 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: Confocal Laser Endomicroscopy; Confocal laser microendoscopy (CLE) as a new non-invasive imaging technique can be used for "optical biopsy", which can perform real-time microscopic information of tissue in vivo at cellular level with resolutions up to 1μm and magnifications up to 1000 times. CLE is now being increasingly used with very promising results in gastroenterology, especially in the diagnostic investigation of Barret's esophagus, stomach cancer, colorectal cancer and various lesions of the biliary tract. With an intravenous injection of fluorescein, probe-based CLE (pCLE: GastroFlex probe with the Cellvizio laser system, Mauna Technologies, Paris, France) allows us to view the interstitial spaces, cells, and small capillaries in a window of 240 μm and to a depth of 60 μm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCLE diagnostic classification	Evaluation of pCLE diagnostic performance for the diagnosis of Laryngeal Lesions when associated with other diagnostic information.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the image analysis by machine learning	Quantitative image features are calculated in the pCLE images by machine learning	6 months

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Study Chair: Huawei Li, PhD &MD, Otorhinolaryngology Department of Eye & ENT Hospital, Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ANTICIPATED): December 21, 2020

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (ACTUAL): October 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 4, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Optical biopsy; Probe-based confocal laser endomicroscopy
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: 20170601

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