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

Probe-based Confocal Laser Endomicroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04139889
• Other study ID #: 20170601
• Status: Recruiting
• Start date: June 1, 2017
• Est. completion date: December 21, 2020

Study information

• Verified date: January 2020
• Source: Eye & ENT Hospital of Fudan University
• Contact: Lingjie Wu, PhD &MD
• Phone: +86-15821574627
• Email: wulingjie116[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 21, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laryngeal Leiomyoma
• Leiomyoma
• Probe-based Confocal Laser Endomicroscopy

Intervention

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.

Locations

Country	Name	City	State
China	Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCLE diagnostic classification	Evaluation of pCLE diagnostic performance for the diagnosis of Laryngeal Lesions when associated with other diagnostic information.	6 months
Secondary	the image analysis by machine learning	Quantitative image features are calculated in the pCLE images by machine learning	6 months