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NCT Number: NCT07538947

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

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

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bronchoscopic navigation with CLE

Procedure

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

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. Improvement of biopsy yield using CLE imaging criteria

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

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

  2. Identification of NSCLC histological subtypes using CLE imaging

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lucie Schnedecker

CONTACT

[email protected]

+33 383156167

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Confocal Laser Endomicroscopy (CLE) Score for the Detection of Non-Small Cell Lung Cancer (NSCLC) and Rapid Surgical Decision-Making

Acronym: SCORACLE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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