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

NCT07060378 | Recruiting DMC

• 1 other identifier: KS25026
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Exploring the Clinical Application Value of Contrast Enhancement Features in CE-EBUS Images for the Diagnosis of Pulmonary Lesions and Intrapulmonary Lymph Nodes

Conditions

Lung Lesions; Mediastinal and Hilar Lymph Node Enlargement

Keywords

CE-EBUS; Ultrasound Contrast Agent; Microbubbles

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy

  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

  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 Outcomes (2)

• Sensitivity, specificity, positive predictive value and negative predictive value of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy

  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

  6 months post-procedure

Study Arms (1)

Contrast-Enhanced Endobronchial Ultrasound

EXPERIMENTAL

Device: Contrast-enhanced endobronchial ultrasound

Interventions

Contrast-enhanced endobronchial ultrasound DEVICE

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.

Contrast-Enhanced Endobronchial Ultrasound

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (2)

• McGrath S, Shen YJ, Aragaki M, Motooka Y, Koga T, Gregor A, Bernards N, Cherin E, Demore CEM, Yasufuku K, Matsuura N. Imaging Microbubbles With Contrast-Enhanced Endobronchial Ultrasound. Ultrasound Med Biol. 2024 Jan;50(1):28-38. doi: 10.1016/j.ultrasmedbio.2023.08.020. Epub 2023 Oct 7.

  PMID: 37813701 BACKGROUND

• Suriano I, Frasca L, Longo F, Sarubbi A, Tacchi G, Crucitti P. Diagnostic Yield of CE-EBUS in Mediastinal and Hilar Lymphadenopathy: A Preliminary Study. J Clin Med. 2025 Apr 18;14(8):2800. doi: 10.3390/jcm14082800.

  PMID: 40283633 BACKGROUND

Central Study Contacts

Jiayuan sun

CONTACT

+1511 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: Vice-President of the hospital

Model Details: Contrast-Enhanced Endobronchial Ultrasound

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 11, 2025
• Study Start: July 10, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)