CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Diagnostic accuracy of ex vivo CLE versus ROSE for malignancy detection in peripheral pulmonary lesions — Intraoperative - within 30 minutes of each biopsy specimen retrieval
  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.

Trial sites (1)

More Guangzhou Medical University trials in China

Other trials for the same condition