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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

ConditionNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient for whom endobronchial navigation-guided biopsy is indicated

Complete medical data (CLE images and histopathological results)

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • bronchoscopic navigation with CLE

    Procedure/Surgery

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

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: CLE based bronchoscopic navigation Group1 intervention

Trial outcomes

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

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

Secondary outcomes

1

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)
2

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Central Hospital, Nancy, France

Lead sponsor

Source ClinicalTrials.gov
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