NCT06910046

GGO-dominant PPLs Diagnosis Using CLE and ssRAB-guided Cryobiopsy

Ground-glass Opacity-dominant Peripheral Pulmonary Lesions Diagnosis Using Confocal Laser Endomicroscopy and Shape-sensing Robotic-assisted Bronchoscopy Guided Cryobiopsy: GLASS-CLEAR Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the diagnostic performance and safety of cryobiopsy for ground-glass opacity (GGO)-dominant peripheral pulmonary lesions (PPLs) under the guidance of shape-sensing robotic-assisted bronchoscopy (ssRAB) combined with confocal laser endomicroscopy (CLE). Additionally, the study aims to establish CLE interpretation criteria for GGO-dominant PPLs based on histopathological characteristics and validate the proposed criteria.

Detailed description

This is a single-arm, single-center, and prospective study. Approximately 119 patients with GGO-dominant PPLs will be enrolled to undergo CLE and ssRAB-guided cryobiopsy for the diagnosis of lesions. During the procedure, CLE will be used to examine the lesion. The primary endpoint is the diagnostic yield of the procedure. The secondary endpoints include the diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the procedure, CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions, and the complication rate.

Conditions

• Lung Ground-Glass Opacity

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CLE and ssRAB-guided cryobiopsy	All procedures are performed under general anesthesia with endotracheal intubation and mechanical ventilation. A conventional flexible bronchoscope is used to examine the subject's airway and clear the secretion. After the registration procedure is completed, the catheter of the ssRAB system is navigated to the target lesion. Cone beam computed tomography (CBCT) is used to confirm whether the target lesion has been reached. After that, an appropriate CLE probe is inserted. Right before CLE imaging, 2.5 ml of 10% fluorescein sodium is administered intravenously. CLE is then used to examine the target lesion. Based on real-time CLE imaging, the optimal biopsy location is identified and localized on the fluoroscopy. After CLE imaging, the CLE probe is retracted, followed by cryobiopsy at the same location under fluoroscopy guidance. Rapid on-site evaluation is available during the procedure to assess sample adequacy.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2025-04-04
• Last updated: 2025-04-06

Locations

1 site across 1 country: China