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

NCT ID: NCT07060378

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-10

Study Completion Date

2026-01-30

Brief Summary

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

Detailed Description

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Conditions

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Lung Lesions Mediastinal and Hilar Lymph Node Enlargement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Contrast-Enhanced Endobronchial Ultrasound
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Contrast-Enhanced Endobronchial Ultrasound

Group Type EXPERIMENTAL

Contrast-enhanced endobronchial ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiayuan Sun

Vice-President of the hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiayuan sun

Role: CONTACT

+1511 86-021-22200000

Facility Contacts

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jiayuan sun

Role: primary

+1511 86-021-22200000

References

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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.

Reference Type BACKGROUND
PMID: 37813701 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40283633 (View on PubMed)

Other Identifiers

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KS25026

Identifier Type: -

Identifier Source: org_study_id

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