Contrast-enhanced endobronchial ultrasound for lung lesions and chest lymph nodes

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

This test checks whether adding a microbubble contrast agent to endobronchial ultrasound helps diagnose lung lesions and enlarged intrathoracic lymph nodes in adults who need EBUS-TBNA.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07060378 on ClinicalTrials.gov

What this trial studies

This interventional single-center study uses contrast-enhanced endobronchial ultrasound (CE-EBUS) during EBUS-TBNA to record enhancement patterns of central pulmonary lesions and intrathoracic lymph nodes. Adult patients with CT or PET/CT findings suggesting central lung lesions or enlarged intrathoracic lymph nodes who are scheduled for diagnostic or staging EBUS-TBNA are enrolled. Contrast enhancement features on CE-EBUS images will be compared with pathological results from TBNA to determine diagnostic value. Standard exclusion criteria include contrast hypersensitivity and significant cardiac or pulmonary comorbidities that contraindicate contrast use or EBUS-TBNA.

Who should consider this trial

Good fit: Adults over 18 with central parenchymal lung lesions adjacent to the airway or at least one intrathoracic lymph node enlargement (short diameter >1 cm or PET/CT uptake SUV >2.5) who are scheduled for EBUS-TBNA and have no contraindications to ultrasound contrast are ideal candidates.

Not a fit: Patients with peripheral lesions not accessible by EBUS, those with known hypersensitivity to ultrasound contrast, or with severe cardiac or pulmonary conditions that contraindicate contrast or EBUS-TBNA are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, CE-EBUS could improve real-time characterization of lesions and lymph nodes, potentially increasing diagnostic accuracy and reducing repeat procedures.

How similar studies have performed: Contrast-enhanced ultrasound has shown diagnostic value in other organs, and small CE-EBUS pilot reports suggest improved lesion characterization, but large, definitive trials are still limited.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jiayuan sun

Conditions Lung Lesions; Mediastinal and Hilar Lymph Node Enlargement; CE-EBUS; Ultrasound Contrast Agent; Microbubbles