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

January 4, 2020 updated by: Eye & ENT Hospital of Fudan University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pCLE diagnostic classification
Time Frame: 6 months
Evaluation of pCLE diagnostic performance for the diagnosis of Laryngeal Lesions when associated with other diagnostic information.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the image analysis by machine learning
Time Frame: 6 months
Quantitative image features are calculated in the pCLE images by machine learning
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eye & ENT Hospital of Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Huawei Li, PhD &MD, Otorhinolaryngology Department of Eye & 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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