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CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment

StatusRecruiting
PhaseNot specified
Started
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Record History

  1. Study First Submitted
The goal of this observational study is to evaluate the diagnostic efficacy of Confocal Laser Endomicroscopy (CLE) compared to Rapid On-Site Evaluation (ROSE) for ex vivo lung biopsy specimens obtained via bronchoscopy. The main questions it aims to answer are: 1. Does CLE provide diagnostic accuracy comparable to ROSE for the real-time assessment of peripheral pulmonary lesions? 2. What is the level of consistency between CLE-detected malignant architectural patterns and ROSE-identified atypical cells? Participants with peripheral pulmonary lesions (5-50 mm) undergoing navigational bronchoscopy will have their first retrieved biopsy specimen sequentially analyzed. The specimen will undergo CLE scanning first, followed immediately by ROSE cytology, before being fixed for final histopathological examination (the gold standard). CLE and ROSE interpreters will be blinded to the final pathological results and to each other's findings. Diagnostic performance, inter-modality agreement (using Kappa statistics), and procedure times will be analyzed to determine if CLE can serve as a non-consumptive alternative to ROSE.
Trial Details
NCT Number NCT07725510
Lead Sponsor Guangzhou Medical University
Conditions
(from sponsor)		 Peripheral Pulmonary Lesions (PPLs)
Related terms Disease
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov