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 (SCORACLE)

April 13, 2026 updated by: SCHNEDECKER Lucie, Central Hospital, Nancy, France

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CLE based bronchoscopic navigation Group
Procedure: bronchoscopic navigation with CLE
bronchoscopic navigation with real-time imagine (Confocal Laser Endomicroscopy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the endoscopic procedure and confirmed after biopsy analysis (up to 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
Accuracy of CLE imaging criteria in differentiating NSCLC subtypes (e.g., squamous cell carcinoma, adenocarcinoma, carcinoid tumors) compared with standard histopathology.
During the procedure and confirmed after biopsy analysis (up to 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025PI085

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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