Real-Time Imaging to Improve Lung Cancer Diagnosis : Comparing Confocal Laser Endomicroscopy (CLE) With Standard Biopsy for Quicker and Safer Detection of Non-Small Cell Lung Cancer

Central Hospital, Nancy, France70 enrolled

Overview

The goal of this observational study is to evaluate whether confocal laser endomicroscopy (CLE) can improve the real-time diagnosis of non-small cell lung cancer (NSCLC) in patients undergoing bronchoscopic biopsy for suspected lung tumors. The main questions it aims to answer are: * Can a high-specificity CLE-based score accurately identify NSCLC during endoscopic procedures? * Can CLE imaging criteria improve biopsy yield and help differentiate histological subtypes (e.g., squamous cell carcinoma, adenocarcinoma, carcinoid tumors)? Participants will: * Undergo standard bronchoscopic navigation procedures with additional real-time imaging using CLE and biopsy * Have CLE findings compared with standard histopathological analysis of biopsy samples

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non Small Cell Lung Cancer

Interventions

bronchoscopic navigation with CLEPROCEDURE

bronchoscopic navigation with real-time imagine (Confocal Laser Endomicroscopy)

Medical Language ↔ Plain English

Inclusion Criteria: * Patient for whom endobronchial navigation-guided biopsy is indicated * Complete medical data (CLE images and histopathological results) Exclusion Criteria: * Persons referred to in Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code: * Individuals under 18 years of age * Adult persons subject to legal protection measures (guardianship, curatorship, or judicial protection) * Adult persons unable to express their consent * Persons deprived of liberty by judicial or administrative decision, and persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1

Outcomes

Primary Outcomes

Diagnostic accuracy of the CLE-based score for non-small cell lung cancer (NSCLC) detection

Proportion of cases in which the CLE imaging score correctly identifies NSCLC, using standard histopathology from biopsy samples as the reference standard

Time frame: During the endoscopic procedure and confirmed after biopsy analysis (up to 7 days)

Secondary Outcomes

Improvement of biopsy yield using CLE imaging criteria

Proportion of biopsy samples considered adequate for histopathological diagnosis when guided by CLE imaging features.

Time frame: During the endoscopic procedure and confirmed after pathology analysis (up to 7 days)

Identification of NSCLC histological subtypes using CLE imaging

Accuracy of CLE imaging criteria in differentiating NSCLC subtypes (e.g., squamous cell carcinoma, adenocarcinoma, carcinoid tumors) compared with standard histopathology.

Time frame: During the procedure and confirmed after biopsy analysis (up to 7 days)