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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07538947
Acronym
SCORACLE
Enrollment
70
Registered
2026-04-20
Start date
2026-04-03
Completion date
2026-06-15
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

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

Interventions

PROCEDUREbronchoscopic navigation with CLE

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

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of the CLE-based score for non-small cell lung cancer (NSCLC) detectionDuring 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

MeasureTime frameDescription
Improvement of biopsy yield using CLE imaging criteriaDuring 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.
Identification of NSCLC histological subtypes using CLE imagingDuring 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.

Countries

France

Contacts

CONTACTLucie Schnedecker
L.SCHNEDECKER@chru-nancy.fr+33 383156167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026