A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes

July 10, 2025 updated by: Jiayuan Sun, Shanghai Chest Hospital
Exploring the Clinical Application Value of Contrast Enhancement Features in CE-EBUS Images for the Diagnosis of Pulmonary Lesions and Intrapulmonary Lymph Nodes

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >18 years old；
  • Enlargement of at least one intrathoracic LN (short diameter > 1 cm) or central parenchymal lung lesions adjacent to the airway detected on chest CT, or increased fluorodeoxyglucose uptake in at least one intrathoracic lymph node on PET / CT (standardized uptake value > 2.5)；
  • CP-EBUS-TBNA is required to determine the diagnosis or staging, the patient agreed to undergo CE-EBUS, and there were no contraindications to EBUS-TBNA;
  • Patients who have good compliance and sign informed consent.

Exclusion Criteria:

  • Patients with known hypersensitivity to ultrasound contrast components;
  • Patients with severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg);
  • Patients with angina pectoris, acute coronary syndrome, clinically unstable ischemic heart disease, heart failure, cardiac dysfunction, and cardiac disease with right-to-left shunting;
  • Patients with uncontrolled essential hypertension and adults with respiratory distress syndrome;
  • Pregnant or lactating women；
  • Patients with contraindications to bronchoscopy；
  • Patients with other conditions that, in the opinion of the investigator, make the patient unsuitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Contrast-Enhanced Endobronchial Ultrasound
Device: Contrast-enhanced endobronchial ultrasound
Using CE-EBUS to observe pulmonary lesions and abnormal enlarged intrathoracic lymph nodes, the enhancement characteristics of benign and malignant lesions under CE-EBUS were extracted for both conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy
Time Frame: 6 month post-procedure
Diagnostic accuracy is defined as the number of lesions correctly identified as malignant or benign divided by the total number of lesions using CE-EBUS interpretation criteria.
6 month post-procedure
Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrapulmonary lesions
Time Frame: 6 month post-procedure
Diagnostic accuracy was defined as the number of lesions correctly identified as malignant or benign divided by the total number of lesions using the CE-EBUS interpretation criteria.
6 month post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity, positive predictive value and negative predictive value of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy
Time Frame: 6 months post-procedure

Sensitivity is defined as the number of lesions correctly identified as malignant using the CE-EBUS interpretation criteria divided by the total number of malignant lesions.

Specificity is defined as the number of lesions correctly identified as benign using the CE-EBUS interpretation criteria divided by the total number of benign lesions.

Positive predictive value is the percentage of truly malignant lesions among all lesions identified as malignant using the CE-EBUS interpretive criteria.

Negative predictive value is the percentage of truly benign lesions among all lesions identified as benign using CE-EBUS interpretive criteria.
6 months post-procedure
Sensitivity, specificity, positive predictive value and negative predictive value of CE-EBUS in the differential diagnosis of benign and malignant intrapulmonary lesions
Time Frame: 6 months post-procedure

Sensitivity is defined as the number of lesions correctly identified as malignant using the CE-EBUS interpretation criteria divided by the total number of malignant lesions.

Specificity is defined as the number of lesions correctly identified as benign using the CE-EBUS interpretation criteria divided by the total number of benign lesions.

Positive predictive value is the percentage of truly malignant lesions among all lesions identified as malignant using the CE-EBUS interpretive criteria.

Negative predictive value is the percentage of truly benign lesions among all lesions identified as benign using CE-EBUS interpretive criteria.
6 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

June 22, 2025

First Submitted That Met QC Criteria

July 10, 2025

First Posted (Actual)

July 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS25026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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