Solitary pulmonary nodule has become a major challenge in respiratory clinical practice. According to published guidelines, their management often requires close CT follow up, PET CT and invasive procedures to obtain a definite histology. In this context, innovative endoscopic techniques refered as navigational bronchoscopy have proved to be efficient, for the localization and sampling of peripheral lung nodules. However, these techniques are unable to differentiate malignant lesions from benign ones, in-vivo, in real time. Confocal endo-microscopy (CELLVIZIO) of the distal lung - also refered as distal lung probe based confocal laser endo-microscopy or alveolar lung endo-microscopy - allows in-vivo imaging of the distal lung structures in real time. This prospective trial we will assess confocal endoscopy as a tool to localize the peripheral lung nodules and to differentiate benign from tumoral lesions. Objective(s) 1. To demonstrate that confocal endo-microscopy is not inferior to navigational endoscopy for the localisation of peripheral lung nodule 2. To demonstrate that confocal endoscopy can differentiate benign from malignant tumors Experimental design: Multicentric prospective controlled trial, conducted in three academic centers, specialized in interventional bronchoscopy, equipped with both navigational bronchoscopy and probe based confocal endo-microscopy. Subjects with peripheral lung nodule requiring navigational bronchoscopy will be explored using both Confocal endoscopy AND navigational bronchoscopy. Confocal probe will be inserted in the same catheter as used for the navigational bronchoscopy and confocal images will be recorded before sampling. An ancillary study using topical methylene blue as in situ will be conducted at the Rouen University Center. An ancillary protocol includes the use of in situ methylene blue deposition and 660 confocal endo-microscopy analysis.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Sensitivity of confocal imaging (solid pattern) for the diagnostic of the pulmonary nodule
Timeframe: six months after the procedure