Optical Biopsy for Peripheral Pulmonary Lesions

Confocal Laser Endomicroscopy in the Diagnosis of Peripheral Pulmonary Lesions

The purpose of the study is to describe confocal laser endomicroscopy (CLE) interpretation criteria for different types of peripheral pulmonary lesions (PPLs), with histopathological correlation, and to perform the validation of these criteria.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Pulmonary Lesions

Detailed Description

CLE is a modern imaging technique that uses an excitation laser light to create real-time microscopic images of tissues. During transbronchial lung biopsy, CLE has the potential to provide real-time non-invasive diagnosis of PPLs ("optical biopsy"). In this study, we will obtain CLE images within the target lesion before taking a biopsy during transbronchial lung biopsy of PPLs. We will compare the results of the "optical biopsy" with the corresponding histopathological results and develop CLE interpretation criteria for different types of PPLs. In addition, we will perform the validation of these criteria to evaluate the ability of CLE to discriminate between benign and malignant PPLs.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Jiayuan Sun; Phone Number: 1511 +86-021-22200000; Email: jysun1976@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with peripheral pulmonary lesions scheduled for transbronchial lung biopsy.

Description

Inclusion Criteria:

1. Patients older than 18 years.
2. Chest CT shows peripheral pulmonary lesions (peripheral pulmonary lesions are lesions beyond the segmental bronchi that are invisible during bronchoscopy), and transbronchial biopsy is considered necessary and feasible.
3. Patients who have good compliance and sign informed consent.

Exclusion Criteria:

1. Patients with known allergy for fluorescein.
2. Pregnant or lactating women.
3. Patients with contraindications of bronchoscopy.
4. The investigators believe that patient has other conditions that are not suitable for the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with peripheral pulmonary lesions; A total of 150 patients with peripheral pulmonary lesions who meet the inclusion and exclusion criteria will be prospectively enrolled, of which 100 patients will be used for the development of CLE interpretation criteria, and 50 patients will be used for the validation of the criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of CLE in differential diagnosis of benign and malignant PPLs	Diagnostic accuracy is defined as the number of lesions correctly identified as malignant or benign using our proposed CLE interpretation criteria divided by the total number of lesions.	6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity, specificity of CLE in differential diagnosis of benign and malignant PPLs	Sensitivity is defined as the number of lesions correctly identified as malignant using our proposed CLE interpretation criteria divided by the total number of malignant lesions. Specificity is defined as the number of lesions correctly identified as benign using our proposed CLE interpretation criteria divided by the total number of benign lesions.	6 months post-procedure
positive predictive value, and negative predictive value of CLE in differential diagnosis of benign and malignant PPLs	The positive predictive value is the percentage of true malignant lesions among all lesions identified as malignant using our proposed CLE interpretation criteria. The negative predictive value is the percentage of true benign lesions among all lesions identified as benign using our proposed CLE interpretation criteria.	6 months post-procedure
Diagnostic accuracy of CLE in differential diagnosis of different types of PPLs	Different types of PPLs include different types of common malignant PPLs (e.g., adenocarcinoma, squamous cell carcinoma, small cell lung carcinoma, etc.) and different types of common benign PPLs (e.g., inflammation, tuberculosis, fungal infection, etc.). Diagnostic accuracy is defined as the number of lesions correctly identified as a specific disease using our proposed CLE interpretation criteria divided by the total number of lesions.	6 months post-procedure
Incidence of complications	Complications mean a composite of procedure related adverse advents during and after the operation.	1 month post-procedure

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Study Director: Jiayuan Sun, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 8, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SHCHE202402

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