Diagnostic Value of Confocal Laser Endomicroscopy (CelTouch) for Peripheral Lung Lesions

This study uses CelTouch to explore patients with lung lesions scheduled for lung biopsy. By comparing with preclinical CLE images and pathological images, CLE diagnostic criteria for benign and malignant lung lesions under the microscope will be established; the performance of CLE in diagnosing peripheral lung lesions will be validated through multicenter clinical research; and a CLE atlas for peripheral lung lesions will be constructed to establish a visual classification diagnostic system for peripheral lung lesions. (1) Comparative Study of In Vivo CLE Images and Pathological Images in the Diagnosis of Peripheral Lung Lesions 1. Collect CLE images and histopathological sections of clearly diagnosed peripheral lung lesions. 2. A diagnostic team composed of 1 bronchoscopy expert, 1 pathology expert, and 2 CLE experts will correlate in vivo and ex vivo CLE images of lung lesions with corresponding pathological images, analyze CLE image characteristics of benign and malignant lung lesions, and establish CLE diagnostic criteria for benign and malignant lung lesions. (2) Validation Study of the Diagnostic Performance of Confocal Laser Endomicroscopy in Peripheral Lung Lesions 1. Multicenter screening of corresponding subjects according to inclusion and exclusion criteria, collection of corresponding videos and images during surgery, and recording of observed characteristic images based on pre-established diagnostic characteristics and criteria. 2. The diagnostic team and sub-center representatives (5 in total) will perform offline interpretation of the collected images and videos, and evaluate the diagnostic performance of CLE in peripheral lung lesions using the accurate diagnostic results obtained from postoperative histopathology or 6-month clinical follow-up as the standard. 3. Establishment of a CLE Atlas and Classification System for Lung Lesions (1) Collect large-scale in vivo and ex vivo CLE images and pathological images of clearly diagnosed lung lesions from multiple centers. (2) Select typical in vivo and ex vivo CLE images of lung lesions with the same pathological type and corresponding pathological images, and jointly describe the CLE image diagnostic characteristics by pathology experts and CLE experts to establish a CLE atlas for peripheral lung lesions. (3) Establish a visual classification system for the internal structure of peripheral lung lesions based on the special signs in CLE images of lung lesions.

NCT Number	NCT07004946
Lead Sponsor	Guangzhou Medical University
Conditions	Peripheral Pulmonary Lesion
Enrollment	286 participants
Start Date	2025-05-31
Primary Completion	2026-06-01 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-04