Optical Biopsy for Peripheral Pulmonary Lesions

N/ANot Yet RecruitingNCT06457087

Shanghai Chest Hospital150 enrolled

Overview

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.

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

150

Conditions

Peripheral Pulmonary Lesions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 6 months post-procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months post-procedure

Incidence of complications

Central Contacts

Jiayuan Sun

CONTACT

+86-021-22200000 jysun1976@163.com

Data from ClinicalTrials.gov

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