CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment

NCT07725510 | Recruiting

• 1 other identifier: ES-2025-229-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does CLE provide diagnostic accuracy comparable to ROSE for the real-time assessment of peripheral pulmonary lesions?
2. 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)

Keywords

peripheral pulmonary lesions; Confocal Laser Endomicroscopy; Rapid On-Site Evaluation; Transbronchial Lung Biopsy; diagnosis

Outcome Measures

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.

  Intraoperative - within 30 minutes of each biopsy specimen retrieval

Secondary Outcomes (6)

• Diagnostic performance of ex vivo CLE

  Intraoperative

• Diagnostic performance of ROSE

  Intraoperative

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

  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

  Intraoperative interpretations, validated post-pathology

• Procedure time: CLE imaging and interpretation time per specimen

  Intraoperative

Study Arms (2)

CLE Group

Ex Vivo Confocal Laser Endomicroscopy (CLE) Imaging and Interpretation

Diagnostic Test: Ex Vivo Confocal Laser Endomicroscopy (CLE) Imaging and Interpretation

ROSE Group

Rapid On-Site Evaluation (ROSE) Imaging and Interpretation

Diagnostic Test: Rapid On-Site Evaluation (ROSE) Imaging and Interpretation

Interventions

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.

CLE Group

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.

ROSE Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• （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.

You may not qualify if:

• （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.

Sponsors & Collaborators

• Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163

Guangzhou, Guangdong, 510100, China

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Disease

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

ZhenDing You

CONTACT

+86 020-81566640; youzhending@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: July 24, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)