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CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment

Recruitingn/aAges 18 Years - anyAllGuangzhou Medical University
NCT07725510 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 patho

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📋 Eligibility rules (as published)
Inclusion Criteria: * （1）Imaging Findings: Presence of a peripheral pulmonary lesion (PPL) measuring 5 to 50 mm in maximum diameter on chest CT scan. （2）Clinical Indication: Patients with a clinical indication for diagnostic flexible bronchoscopy and transbronchial biopsy. （3）Consent: Provision of signed and dated written informed consent prior to any study-specific procedures. Exclusion Criteria: * （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). （2）Coagulopathy: Patients with severe coagulation disorders (e.g., platelets \<50,000/μL, INR \>1.5) not corrected prior to the procedure. （3）Pregnancy/Lactation: Pregnant or lactating women.
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What it tests

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

1 site
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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