Optical Biopsy for Peripheral Pulmonary Lesions

Peripheral Pulmonary Lesions Clinical Trial

Official title:

Confocal Laser Endomicroscopy in the Diagnosis of Peripheral Pulmonary Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457087
• Other study ID #: SHCHE202402
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun
• Phone: +86-021-22200000
• Email: jysun1976[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Pulmonary Lesions

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Incidence of complications	Complications mean a composite of procedure related adverse advents during and after the operation.	1 month post-procedure