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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bronchoscopic navigation with CLE.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Confocal Laser Endomicroscopy (CLE) Score for the Detection of Non-Small Cell Lung Cancer (NSCLC) and Rapid Surgical Decision-Making
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
Interventions
- Procedure bronchoscopic navigation with CLE
bronchoscopic navigation with real-time imagine (Confocal Laser Endomicroscopy)
Primary outcome measures
- Diagnostic accuracy of the CLE-based score for non-small cell lung cancer (NSCLC) detection [Time frame: During the endoscopic procedure and confirmed after biopsy analysis (up to 7 days)]
Secondary outcome measures (2)
- Improvement of biopsy yield using CLE imaging criteria [Time frame: During the endoscopic procedure and confirmed after pathology analysis (up to 7 days)]
- Identification of NSCLC histological subtypes using CLE imaging [Time frame: During the procedure and confirmed after biopsy analysis (up to 7 days)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHRU Nancy — Nancy
Identifiers
NCT: NCT07538947 · 2025PI085