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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Ground-Glass Opacity
• Intervention / Treatment: Diagnostic test: CLE and ssRAB-guided cryobiopsy

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.

• Study Type: Interventional
• Enrollment (Estimated): 119
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiayuan Sun, MD, PhD; Phone Number: 1511 86-021-22200000; Email: jysun1976@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with GGO-dominant peripheral pulmonary lesions; Approximately 119 patients with GGO-dominant PPLs who meet the inclusion and exclusion criteria will be prospectively enrolled. CLE and ssRAB-guided cryobiopsy will be performed to diagnose the lesion.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield	Diagnostic yield is defined as the number of diagnostic lesions divided by the total number of lesions.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	The complications refer to the total of device or procedure related adverse events during or within 1 month after the operation.	1 month
CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions.	The CLE interpretation criteria for different kinds of GGO-dominant PPLs and the diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the proposed criteria in differentiating benign from malignant lesions.	1 year
Diagnostic accuracy	Diagnostic accuracy is calculated according to the standard definition using the classical 2*2 table.	1 year
Diagnostic sensitivity	Diagnostic sensitivity is calculated according to the standard definition using the classical 2*2 table. Malignancy is considered as positive.	1 year
Diagnostic specificity	Diagnostic specificity is calculated according to the standard definition using the classical 2*2 table. Malignancy is considered as positive.	1 year

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Study Director: Jiayuan Sun, MD, PhD, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: confocal laser endomicroscopy; ground-glass opacity; cryobiopsy; robotic-assisted bronchoscopy
• Other Study ID Numbers: IS25061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No