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

NCT06910046 | Not Yet Recruiting

• 1 other identifier: IS25061
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Ground-Glass Opacity

Keywords

ground-glass opacity; robotic-assisted bronchoscopy; confocal laser endomicroscopy; cryobiopsy

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  Diagnostic yield is defined as the number of diagnostic lesions divided by the total number of lesions.

  1 year

Secondary Outcomes (5)

• Diagnostic accuracy

  1 year

• Diagnostic sensitivity

  1 year

• Diagnostic specificity

  1 year

• CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions.

  1 year

• Complication rate

  1 month

Study Arms (1)

Patients with GGO-dominant peripheral pulmonary lesions

EXPERIMENTAL

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

Interventions

CLE and ssRAB-guided cryobiopsy DIAGNOSTIC_TEST

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.

Patients with GGO-dominant peripheral pulmonary lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Study Officials

• Jiayuan Sun, MD, PhD

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun, MD, PhD

CONTACT

86-021-22200000; jysun1976@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

CN (1)