Clinical trial NCT06910046: GGO-dominant PPLs Diagnosis Using CLE and ssRAB-guided Cryobiopsy
Official title: Ground-glass Opacity-dominant Peripheral Pulmonary Lesions Diagnosis Using Confocal Laser Endomicroscopy and Shape-sensing Robotic-assisted Bronchoscopy Guided Cryobiopsy: GLASS-CLEAR Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Ground-Glass Opacity
Keywords: ground-glass opacity
robotic-assisted bronchoscopy
confocal laser endomicroscopy
cryobiopsy
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age≥18 years;
2. Thin-slice chest CT showing GGO-dominant peripheral pulmonary lesions (diameter≥8mm, GGO component≥50%);
3. Suspected pulmonary malignant tumor which requires transbronchial lung biopsy for diagnosis;
4. Patients who have good compliance and sign informed consent.

Exclusion Criteria:

1. Diffuse GGO, suspected of benign or infectious lesions;
2. Preoperative imaging showing the target biopsy lesion adjacent to medium or large blood vessels;
3. Patients with contraindications of bronchoscopy;
4. Presence of concomitant endobronchial lesion during the bronchoscopy procedure;
5. Pregnant or lactating women;
6. Patients with known allergy for fluorescein;
7. The investigators believe that patient has other conditions that are not suitable for the study.

Primary outcomes:
measure: Diagnostic yield
timeFrame: 1 year
Secondary outcomes:
measure: Diagnostic accuracy
timeFrame: 1 year
measure: Diagnostic sensitivity
timeFrame: 1 year
measure: Diagnostic specificity
timeFrame: 1 year
measure: CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions.
timeFrame: 1 year
measure: Complication rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, MD, PhD
role: STUDY_DIRECTOR
References: