Optical Biopsy and Cytological Evaluation for Intrathoracic Lymphadenopathy

NCT ID: NCT07047417

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-07-01

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.

Detailed Description

This is a single-arm, single-center and prospective study. Approximately 150 patients with intrathoracic lymphadenopathy will be included to receive CLE and ROSE for the diagnosis of the lesions. CLE is a modern imaging technique that uses an excitation laser light to create real-time microscopic images of tissues. During transbronchial biopsy, CLE has the potential to provide rea-lime non-invasive diagnosis of intrathoracic lymphadenopathy ('optical biopsy'). Rapid on-site evaluation (ROSE) is an important auxiliary technology for transbronchial biopsy, providing rapid cytopathological evaluation of specimens during operation and feedback on specimen quality and preliminary diagnosis of lesions. In this study, we will obtain CLE images and ROSE images of the target lesion . We will compare the results of the 'optical biopsy' and cytological evaluation with the corresponding histopathological results and develop CLE and ROSE interpretation criteria for different types of intrathoracic lymphadenopathy. In addition, we will perform the validation of these criteria to evaluate the ability of CLE and ROSE to discriminate between benign and malignant intrathoracic lymphadenopathy.

Conditions

Intrathoracic Lymphadenopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with intrathoracic lymphadenopathy

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.

Group Type: EXPERIMENTAL

CLE and ROSE

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age >18 years old.

2. 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.

3. CP-EBUS-TBNA is required to determine the diagnosis or staging.

4. Patients who have good compliance and sign informed consent.

Exclusion Criteria

1. Patients with known allergy for fluorescein.

2. Pregnant or lactating women.

3. Patients with contraindications of bronchoscopy.

4. The investigators believe that patient has other conditions that are not suitable for the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jiayuan Sun

Director, Department of Respiratory Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiayuan Sun

Role: STUDY_DIRECTOR

Shanghai Chest Hospital

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jiayuan Sun

Role: CONTACT

jysun1976@163.com

+86-021-22200000 ext. 1511

Facility Contacts

Jiayuan Sun

Role: primary

jysun1976@163.com

+86-021-22200000 ext. 1511

Other Identifiers

KS25034

Identifier Type: -

Identifier Source: org_study_id