Not Yet RecruitingNot Applicable

Optical Biopsy and Cytological Evaluation for Intrathoracic Lymphadenopathy

China150 participantsStarted 2025-07-01

Plain-language summary

The purpose of this study is to describe and validate confocal laser endomicroscopy(CLE) and rapid on-site evaluation(ROSE) interpretation criteria for different types of intrathoracic lymphadenopathy.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age \>18 years old.
✓. Chest CT shows at least one enlarged intrathoracic lymph node (short axis \>1 cm), or PET / CT shows increased fluorodeoxyglucose uptake (standard uptake value \> 2.5) in at least one intrathoracic lymph node.
✓. CP-EBUS-TBNA is required to determine the diagnosis or staging.
✓. Patients who have good compliance and sign informed consent.

Exclusion criteria

✕. Patients with known allergy for fluorescein.
✕. Pregnant or lactating women.
✕. Patients with contraindications of bronchoscopy.
✕. The investigators believe that patient has other conditions that are not suitable for the study.

What they're measuring

Diagnostic accuracy of CLE combined with ROSE in differential diagnosis of benign and malignant intrathoracic lymphadenopathy

Timeframe: 6 month post-procedure

Trial details

NCT IDNCT07047417

SponsorShanghai Chest Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

Contact for this trial

Jiayuan Sun

+86-021-22200000 jysun1976@163.com

View on ClinicalTrials.gov More Intrathoracic Lymphadenopathy trials