CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuangzhou Medical University

About this trial

The goal of this observational study is to evaluate the diagnostic efficacy of Confocal Laser Endomicroscopy (CLE) compared to Rapid On-Site Evaluation (ROSE) for ex vivo lung biopsy specimens obtained via bronchoscopy. The main questions it aims to answer are:

1. Does CLE provide diagnostic accuracy comparable to ROSE for the real-time assessment of peripheral pulmonary lesions? 2. What is the level of consistency between CLE-detected malignant architectural patterns and ROSE-identified atypical cells? Participants with peripheral pulmonary lesions (5-50 mm) undergoing navigational bronchoscopy will have their first retrieved biopsy specimen sequentially analyzed. The specimen will undergo CLE scanning first, followed immediately by ROSE cytology, before being fixed for final histopathological examination (the gold standard). CLE and ROSE interpreters will be blinded to the final pathological results and to each other's findings. Diagnostic performance, inter-modality agreement (using Kappa statistics), and procedure times will be analyzed to determine if CLE can serve as a non-consumptive alternative to ROSE.

Eligibility criteria

Qualifiers

(1)Imaging Findings: Presence of a peripheral pulmonary lesion (PPL) measuring 5 to 50 mm in maximum diameter on chest CT scan.

Disqualifiers

(1)Contraindications to Bronchoscopy: Patients with severe cardiopulmonary insufficiency or any absolute contraindication to flexible bronchoscopy (e.g., severe hypoxemia, unstable angina, or uncontrolled asthma).

Trial design

Treatments tested in this trial

  • Ex Vivo Confocal Laser Endomicroscopy (CLE) Imaging and Interpretation
  • Rapid On-Site Evaluation (ROSE) Imaging and Interpretation

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Guangzhou Medical University

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Sponsor institution