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

NCT07538947 | Recruiting

• 1 other identifier: 2025PI085
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (2)

• Improvement of biopsy yield using CLE imaging criteria

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

• Identification of NSCLC histological subtypes using CLE imaging

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

Study Arms (1)

CLE based bronchoscopic navigation Group

Procedure: bronchoscopic navigation with CLE

Interventions

bronchoscopic navigation with CLE PROCEDURE

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

CLE based bronchoscopic navigation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at CHRU de Nancy scheduled for endobronchial navigation-guided biopsy due to suspected lung lesions

You may qualify if:

• Patient for whom endobronchial navigation-guided biopsy is indicated
• Complete medical data (CLE images and histopathological results)

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Eukaryotic Initiation Factor-2B

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine Nucleotide Exchange Factors; GTP-Binding Protein Regulators; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Eukaryotic Initiation Factors; Peptide Initiation Factors; Ribosomal Proteins

Central Study Contacts

Lucie Schnedecker

CONTACT

+33 383156167; L.SCHNEDECKER@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pathologist

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 20, 2026
• Study Start: April 3, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

FR (1)