Real-time CLE imaging to speed and improve lung cancer diagnosis
Confocal Laser Endomicroscopy (CLE) Score for the Detection of Non-Small Cell Lung Cancer (NSCLC) and Rapid Surgical Decision-Making
This project will try to see if using confocal laser endomicroscopy (CLE) during bronchoscopic biopsy can diagnose non-small cell lung cancer faster and with fewer or safer biopsies for people with suspected lung tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Nancy) |
| Trial ID | NCT07538947 on ClinicalTrials.gov |
What this trial studies
Researchers will use confocal laser endomicroscopy (CLE) alongside standard bronchoscopic navigation-guided biopsy to capture real-time images of suspected lung tumors. CLE imaging findings will be scored using predefined criteria and directly compared with standard histopathology from biopsy samples to determine diagnostic accuracy and the ability to distinguish histologic subtypes. This observational, single-center study enrolls adults referred for endobronchial navigation-guided biopsy at CHRU Nancy and does not change routine clinical care. The aim is to see whether CLE can improve biopsy yield, provide immediate diagnostic information, and help target sampling during the procedure.
Who should consider this trial
Good fit: Adults who are scheduled for endobronchial navigation-guided biopsy for a suspected lung tumor, can give informed consent, and have CLE images and biopsy pathology available are ideal candidates.
Not a fit: People under 18, adults under legal protection, those unable to consent, persons deprived of liberty or involuntary psychiatric patients, and individuals whose lesions are not reachable by bronchoscopic navigation are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, CLE could provide faster, on-the-spot diagnoses, improve biopsy accuracy, and reduce the need for repeat or more invasive sampling.
How similar studies have performed: Prior small studies and pilot work using CLE in the respiratory tract have shown promising visualization of cellular patterns and potential to assist sampling, but large definitive trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nancy
- CHRU Nancy — Nancy, France (Recruiting)
Study contacts
- Study coordinator: Lucie Schnedecker
- Email: L.SCHNEDECKER@chru-nancy.fr
- Phone: +33 383156167
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.