CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ex Vivo Confocal Laser Endomicroscopy (CLE) Imaging and Interpretation, Rapid On-Site Evaluation (ROSE) Imaging and Interpretation.
- Who it may be relevant to
- Registry conditions: Peripheral Pulmonary Lesions (PPLs). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Comparative Study on the Diagnostic Efficacy of Confocal Laser Endomicroscopy Versus Rapid On-Site Evaluation (ROSE) for Ex Vivo Lung Biopsy Specimens Obtained Via Bronchoscopy
Overview
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.
Interventions
- Diagnostic test Ex Vivo Confocal Laser Endomicroscopy (CLE) Imaging and Interpretation
Following navigational bronchoscopy and target confirmation via radial endobronchial ultrasound (r-EBUS) and in vivo CLE, a lung biopsy is performed. The first retrieved specimen is immediately transferred to the CLE workstation. A CLE expert measures the specimen dimensions and then performs a comprehensive surface scan of the intacttissue using a confocal miniprobe. The operator records the time required for setup and imaging. Based exclusively on the real-time microarchitectural patterns (e.g - Diagnostic test Rapid On-Site Evaluation (ROSE) Imaging and Interpretation
Immediately following the completion of the ex vivo CLE imaging on the same biopsy specimen, the tissue undergoes ROSE processing. A ROSE expert (cytopathologist) performs a smear preparation using the CLE-scanned tissue. The specimen is then stained (e.g., Diff-Quik) and evaluated microscopically. The operator records the time required for smear preparation, staining, and interpretation. The blinded ROSE expert assesses the presence of atypical cells or diagnostic material to render a cytologic
Primary outcome measures
- Diagnostic accuracy of ex vivo CLE versus ROSE for malignancy detection in peripheral pulmonary lesions [Time frame: Intraoperative - within 30 minutes of each biopsy specimen retrieval]
Secondary outcome measures (6)
- Diagnostic performance of ex vivo CLE [Time frame: Intraoperative]
- Diagnostic performance of ROSE [Time frame: Intraoperative]
- Cohen's kappa (κ) for agreement between CLE diagnosis and final histopathology [Time frame: After final pathology available (within 7-10 working days)]
- Cohen's kappa (κ) for agreement between CLE structural findings and ROSE cytological findings on the same specimen [Time frame: Intraoperative interpretations, validated post-pathology]
- Procedure time: CLE imaging and interpretation time per specimen [Time frame: Intraoperative]
- Procedure time: ROSE preparation and interpretation time per specimen [Time frame: Intraoperative]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163 — Guangzhou
Publications
- Gompelmann D, Papaporfyriou A, Bal C, Merza Y, Mosleh B, Oberndorfer F, Tschernko E, Hoda MA, Idzko M. Transbronchial Cryobiopsy under Simultaneous Confocal Laser Endomicroscopy Guidance for Peripheral Pulmonary Lesions: A Pilot Study. Respiration. 2026;105(2):305-311. doi: 10.1159/000548658. Epub 2025 Sep 29. PMID 41021407
Identifiers
NCT: NCT07725510 · ES-2025-229-01