RecruitingNot ApplicableNCT06079970

Confocal Laser Endomicroscopy VERification

Bronchoscopy With and Without Needle-based Confocal Laser Endomicroscopy for Peripheral Lung Nodule Diagnosis: Protocol for a Multicenter Randomized Controlled Trial (CLEVER Trial)

Sponsor

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Enrollment

208 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Lung Cancer Lung Neoplasm Malignant

Summary

The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung lesion analysis on the diagnostic yield in patients with peripheral pulmonary nodules suspect for malignancy. The main question\[s\] it aims to answer are: To determine if the addition of nCLE-imaging to conventional diagnostic bronchoscopic peripheral lung lesion analysis results in an improved diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis out of the total number of patients that have received the diagnostic bronchoscopic procedure). Participants will undergo diagnostic bronchoscopy either with or without the addition of nCLE imaging before each TBNA. Based on the feedback of the CLE images on (in)correct placement of the needle, the needle might be repositioned before sampling. Comparison between the diagnostic yield of these groups will be done including subgroup analysis.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (CLEVER) is testing whether confocal laser endomicroscopy — a highly magnified, real-time imaging technique performed through a bronchoscope (a flexible camera passed into the airways) — can improve the accuracy of diagnosing suspicious peripheral lung nodules without needing more invasive procedures. **You may be eligible if...** - You are 18 years or older - You have a suspected cancerous lung lesion located in the outer parts of the lung, beyond where a standard bronchoscope can reach - The lesion shows a "bronchus sign" on CT scan (meaning an airway leads toward it) or has a high estimated chance of being cancer - Your medical team has already recommended a bronchoscopic workup **You may NOT be eligible if...** - Your lung lesion is centrally located and visible on standard bronchoscopy - You do not have a bronchus sign on CT or low suspicion of malignancy - You are not medically suitable for a bronchoscopic procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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