Optical Biopsy and Cytological Evaluation for Intrathoracic Lymphadenopathy

NCT07047417 | Not Yet Recruiting

• 1 other identifier: KS25034
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

confocal laser endomicroscopy; rapid on-site evaluation; intrathoracic lymphadenopathy

Outcome Measures

Primary Outcomes (1)

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

  Diagnostic accuracy is defined as the number of lesions correctly identified as malignant or benign using our proposed CLE and ROSE interpretation criteria divided by the total number of lesions.

  6 month post-procedure

Secondary Outcomes (6)

• Sensitivity, specificity, positive predictive value and negative predictive value of CLE combined with ROSE in differential diagnosis of benign and malignant intrathoracic lymphadenopathy

  6 months post-procedure

• Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of CLE alone in differential diagnosis of benign and malignant intrathoracic lymphadenopathy

  6 months post-procedure

• Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of ROSE alone in differential diagnosis of benign and malignant intrathoracic lymphadenopathy

  6 months post-procedure

• Diagnosis accuracy of CLE combined with ROSE in differential diagnosis of different types of intrathoracic lymphadenopathy

  6 months post-procedure

• Diagnosis accuracy of CLE or ROSE alone in differential diagnosis of different types of intrathoracic lymphadenopathy

  6 months post-procedure

Study Arms (1)

Patients with intrathoracic lymphadenopathy

EXPERIMENTAL

Approximately 150 patients with intrathoracic lymphadenopathy who meet the inclusion and exclusion criteria will be prospectively included. CLE and ROSE will be performed to diagnose the lesion. 100 patients will be used to establish CLE and ROSE interpretation criteria, and 50 patients will be used for criteria validation.

Diagnostic Test: CLE and ROSE

Interventions

CLE and ROSE DIAGNOSTIC_TEST

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.

Patients with intrathoracic lymphadenopathy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 20030, China

Location

Study Officials

• Jiayuan Sun

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun

CONTACT

+86-021-22200000; jysun1976@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)