Clinical Utility of Needle-Based Confocal Laser Endomicroscopy for Peripheral Pulmonary Lesions

Condition(s) studied

Investigational drug(s) / intervention(s)

Confocal Laser Endomicroscopy: After successful localization of the peripheral pulmonary lesion using radial probe endobronchial ultrasound, a needle-based confocal laser endomicroscopy probe will be advanced through the same guide sheath. Following intravenous administration of 200 mg fluorescein sodium diluted in 8 mL of normal saline, the probe will be placed in gentle contact with the target lesion to acquire real-time microscopic images. A 1.4-mm probe will be used whenever feasible; a 0.8-mm probe may be used when the larger probe cannot pass through the working channel or guide sheath. The probe position may be adjusted to obtain diagnostically meaningful images. Images will be recorded before bronchoscopic tissue sampling and subsequently evaluated using predefined criteria for malignant and benign lesions. The nCLE findings will be compared with the final diagnosis established by histopathology and follow-up when necessary.

Study summary

This prospective, multicenter diagnostic accuracy study will evaluate the clinical utility of needle-based confocal laser endomicroscopy (nCLE) for differentiating malignant from benign peripheral pulmonary lesions (PPLs). A total of 100 participants undergoing bronchoscopic evaluation of PPLs will be enrolled at three hospitals in China.

Following successful lesion localization using radial endobronchial ultrasound, nCLE imaging will be performed after intravenous administration of fluorescein, followed by standard bronchoscopic tissue sampling. nCLE findings will be compared with the final diagnosis established by histopathology, surgical pathology, or six-month clinical and imaging follow-up when necessary.

The primary outcomes are the sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy of nCLE. Procedure duration and procedure-related adverse events will also be recorded. The investigators hypothesize that nCLE can accurately distinguish malignant from benign PPLs in real time.

Eligibility

Primary outcome measure(s)

• Diagnostic Accuracy of Needle-Based Confocal Laser Endomicroscopy for Differentiating Malignant From Benign Peripheral Pulmonary Lesions — Up to 6 months after the index bronchoscopy

Trial sites (3)

More First Affiliated Hospital of Ningbo University trials in China