Recruiting NCT07060378
A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Contrast-enhanced endobronchial ultrasound.
- Who it may be relevant to
- Registry conditions: Lung Lesions, Mediastinal and Hilar Lymph Node Enlargement. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Exploring the Clinical Application Value of Contrast Enhancement Features in CE-EBUS Images for the Diagnosis of Pulmonary Lesions and Intrapulmonary Lymph Nodes
Interventions
- 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.
Primary outcome measures
- Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy [Time frame: 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]
Secondary outcome measures (2)
- 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, 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Publications
- 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
- 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
Identifiers
NCT: NCT07060378 · KS25026