CLE vs ROSE for ex vivo lung biopsy assessment in peripheral pulmonary lesions
Official title: 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
Run by Guangzhou Medical University · NCT07725510 · Data updated 2026-11-12
This study tests whether Confocal Laser Endomicroscopy can match Rapid On-Site Evaluation for diagnosing peripheral lung lesions from biopsy samples.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | June 15, 2026 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT07725510 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients with peripheral pulmonary lesions 5–50 mm undergoing diagnostic navigational bronchoscopy and transbronchial biopsy.
✕Probably not a fit
Patients whose lesions are not easily characterized by CLE or ROSE may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares two real-time diagnostic methods for ex vivo biopsy material collected during navigational bronchoscopy in patients with peripheral pulmonary lesions (5–50 mm). Each retrieved specimen is scanned with CLE first, then evaluated by ROSE before final histopathology serves as the reference standard. Interpreters for CLE and ROSE are blinded to each other’s findings and to the final pathology to reduce bias. Diagnostic performance and agreement between CLE and ROSE will be analyzed to see if CLE can provide comparable real-time diagnostic information. The study is conducted at a single center in Guangzhou, with eligibility limited to patients undergoing diagnostic bronchoscopy for suspected PPLs and meeting safety criteria for the procedure.
Why it matters
Potential benefit: If successful, CLE could offer a real-time alternative or complement to ROSE in guiding biopsy decisions for PPLs.
How similar studies have gone: Previous work in related ex vivo and in vivo imaging approaches has shown promise, but direct head-to-head comparisons like this are relatively limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: ZhenDing You
- Email: youzhending@163.com
- Phone: +86 020-81566640
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.