Confocal Laser Endomicroscopy for Lung Cancer Diagnosis

This study is looking at a new way to help doctors diagnose lung cancer more accurately. It's for people aged 18 and older who have a suspected lung lesion (an abnormal area) that doctors think might be cancer. The study compares a standard procedure called conventional diagnostic bronchoscopy with a new technique called Needle Based Confocal Laser Endomicroscopy (nCLE). nCLE uses a special camera on a needle to get real-time, microscopic images of the lung tissue during the bronchoscopy. The main goal is to see if adding nCLE helps doctors get a more definitive diagnosis from the bronchoscopy. This study plans to enroll 208 participants.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It is a randomized clinical trial, which means participants will be assigned by chance to one of the study groups.
What's involved
Participants will undergo a bronchoscopy procedure. The study will follow participants for up to 6 months after their bronchoscopy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up to 6 months after their bronchoscopy procedure.

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NCT06079970

Confocal Laser Endomicroscopy VERification

Recruiting
NAAges 18+InterventionalDiagnostic
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
~208 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Neelde Based Confocal Laser EndomicroscopyConventional diagnostic bronchoscopy

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic yield (intermediate definition)
Measured over After all patients have been included and followed up to 6 months after bronchoscopy (expected total time frame 2 years)
Lung Cancer
Lung Neoplasm Malignant
Carcinoma, Non-Small-Cell Lung
Neoplasm of Lung
5 sites across 5 states
New York1
Austria1
Czechia1
Greece1
Netherlands1
  • Jouke Annema, Prof. dr. · PRINCIPAL_INVESTIGATOR · Amsterdam UMC

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  • Diagnostic yield (intermediate definition)After all patients have been included and followed up to 6 months after bronchoscopy (expected total time frame 2 years)

    Diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis \[either malignant, specific benign or non-specific benign confirmed as benign in follow-up\], relative to the total number of patients that underwent the diagnostic bronchoscopic procedure). If patients with multiple lesions are included, the diagnostic yield will be computed per nodule.