CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment

July 23, 2026 updated by: Li Shiyue, Guangzhou Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510100
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CLE Group
Ex Vivo Confocal Laser Endomicroscopy (CLE) Imaging and Interpretation
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.
ROSE Group
Rapid On-Site Evaluation (ROSE) Imaging and Interpretation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Intraoperative - within 30 minutes of each biopsy specimen retrieval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of ex vivo CLE
Time Frame: Intraoperative
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.
Intraoperative
Diagnostic performance of ROSE
Time Frame: Intraoperative
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.
Intraoperative
Cohen's kappa (κ) for agreement between CLE diagnosis and final histopathology
Time Frame: After final pathology available (within 7-10 working days)
Measures inter-rater/modality concordance beyond chance agreement.
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
Cross-validation of malignant architectural patterns (CLE) vs. presence of atypical cells (ROSE).
Intraoperative interpretations, validated post-pathology
Procedure time: CLE imaging and interpretation time per specimen
Time Frame: Intraoperative
Measured in seconds/minutes from probe placement to definitive optical diagnosis.
Intraoperative
Procedure time: ROSE preparation and interpretation time per specimen
Time Frame: Intraoperative
Measured in seconds/minutes from touch imprint/smear to definitive cytological diagnosis.
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 14, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES-2025-229-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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