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CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment

ConditionPeripheral Pulmonary Lesions (PPLs)
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

This trial does not accept healthy volunteers

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 population

This study will enroll 60 adult participants with newly identified peripheral pulmonary lesions (PPLs) who are scheduled to undergo diagnostic navigational bronchoscopy. The target population consists of patients presenting with solitary or multiple pulmonary nodules or masses ranging from 5 to 50 mm in maximum diameter on computed tomography (CT) imaging, who have a clinical indication for tissue diagnosis. All participants must be surgical candidates fit enough to tolerate flexible bronchoscopy and meet standard pre-procedural coagulation parameters. Pregnant or lactating women, as well as individuals with severe cardiopulmonary insufficiency or uncorrectable coagulopathy, will be excluded to ensure procedural safety. Written informed consent will be obtained from all participants prior to enrollment. The study population is specifically selected to evaluate the diagnostic efficacy of novel optical biopsy (CLE) against the current standard (ROSE) in lesions where tissue acquisition

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ex Vivo Confocal Laser Endomicroscopy (CLE) Imaging and Interpretation

    Diagnostic test

    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., loss of normal alveolar honeycombing, dense cell clusters), the blinded CLE expert renders a preliminary diagnosis of "benign" or "malignant." Crucially, this intervention is non-consumptive, meaning the tissue remains physically intact and structurally preserved after the scan for the subsequent ROSE procedure.

  • Rapid On-Site Evaluation (ROSE) Imaging and Interpretation

    Diagnostic test

    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 cytological diagnosis of "benign" or "malignant." Unlike the preceding CLE step, this intervention is consumptive, as it requires the physical disruption of the tissue architecture to transfer cellular material onto glass slides.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: CLE Group1 intervention
Group B: ROSE Group1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of ex vivo CLE versus ROSE for malignancy detection in peripheral pulmonary lesions

Using final histopathology as the gold standard, diagnostic accuracy (proportion of correct benign/malignant classifications) will be calculated for both ex vivo confocal laser endomicroscopy (CLE) and rapid on-site evaluation (ROSE). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy with 95% confidence intervals will be derived from 2×2 contingency tables for each modality.

Time frame
Intraoperative - within 30 minutes of each biopsy specimen retrieval

Secondary outcomes

1

Diagnostic performance of ex vivo CLE

Using final histopathology as the gold standard, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ex vivo confocal laser endomicroscopy (CLE) for detecting malignancy will be calculated, along with 95% confidence intervals.

Time frame
Intraoperative
2

Diagnostic performance of ROSE

Using final histopathology as the gold standard, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ROSE will be calculated based on touch imprint cytology performed after CLE imaging.

Time frame
Intraoperative
3

Cohen's kappa (κ) for agreement between CLE diagnosis and final histopathology

Measures inter-rater/modality concordance beyond chance agreement.

Time frame
After final pathology available (within 7-10 working days)
4

Cohen's kappa (κ) for agreement between CLE structural findings and ROSE cytological findings on the same specimen

Cross-validation of malignant architectural patterns (CLE) vs. presence of atypical cells (ROSE).

Time frame
Intraoperative interpretations, validated post-pathology

Other outcomes

Sponsors and contacts

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Guangzhou Medical University

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Sponsor institution

Source ClinicalTrials.gov
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