MedTrace Logo

CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment

NCT07725510 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-07-24

No results posted yet for this study

Summary

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.

Conditions

  • Peripheral Pulmonary Lesions (PPLs)

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., 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.

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 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.

Sponsors & Collaborators

  • Guangzhou Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725510 on ClinicalTrials.gov