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Optical Biopsy and Cytological Evaluation for Intrathoracic Lymphadenopathy

NCT07047417 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-07-02

No results posted yet for this study

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.

Conditions

  • Intrathoracic Lymphadenopathy

Interventions

DIAGNOSTIC_TEST

CLE and ROSE

All patients undergo white light bronchoscopy after general anesthesia to rule out abnormalities in the lumen and clear the airways. After locating the target lymph node using convex probe endobronchial ultrasound (CP-EBUS), the target lymph node is routinely explored using the grayscale, blood flow and elastography modes CP-EBUS. Puncture is performed using a puncture needle under the guidance of CP-EBUS, and then the CLE probe is inserted into the target lymph node through the puncture needle. Sodium fluorescein is intravenously injected before CLE imaging. Under the guidance of CP-EBUS, the CLE probe is slowly moved to examine the target lesion. According to the real-time CLE images, the ideal biopsy location is identified. After the CLE examination is completed, cryobiopsy is performed at the ideal biopsy location confirmed by CLE under the guidance of CP-EBUS. After sampling, ROSE of the samples is performed.

Sponsors & Collaborators

  • Shanghai Chest Hospital

    lead OTHER

Principal Investigators

  • Jiayuan Sun · Shanghai Chest Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-01-01
Completion
2026-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07047417 on ClinicalTrials.gov