Imaging Microbubbles With Contrast-Enhanced Endobronchial Ultrasound.
Sean McGrath, Yu-Jack Shen, Masato Aragaki...
https://pubmed.ncbi.nlm.nih.gov/37813701Actively Recruiting
Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID07060378
A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes
Led by Shanghai Chest Hospital · Updated on 2025-07-11
250
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical value of contrast enhancement features in contrast-enhanced endobronchial ultrasound (CE-EBUS) images to diagnose lung lesions and intrathoracic lymph nodes. This study aims to distinguish between benign and malignant pulmonary and lymph node abnormalities using CE-EBUS, focusing on diagnostic accuracy and detailed imaging characteristics. The study is sponsored by Shanghai Chest Hospital and involves adult participants with specific lung or lymph node conditions. The intervention involves using CE-EBUS to observe pulmonary lesions and enlarged intrathoracic lymph nodes adjacent to the airway. Enhancement characteristics of these lesions will be extracted under CE-EBUS for both benign and malignant conditions. Participants will undergo CE-EBUS as part of diagnosis or staging procedures, with no use of placebo or comparison treatments mentioned. Participants will be monitored for diagnostic accuracy outcomes six months after the procedure, including sensitivity, specificity, positive predictive value, and negative predictive value of CE-EBUS in differentiating benign and malignant lesions. The study includes imaging assessments and clinical evaluations to track these outcomes. Participant involvement includes consenting to CE-EBUS and agreeing to follow-up assessments over six months, with careful screening for contraindications to the procedure.
CONDITIONS
Brief Title
A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes
Who Can Participate
Age: 18Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- Enlargement of at least one intrathoracic lymph node with short diameter over 1 cm or central lung lesions near the airway detected on chest CT
- Increased fluorodeoxyglucose uptake in at least one intrathoracic lymph node on PET/CT with standardized uptake value over 2.5
- Requirement for CP-EBUS-TBNA to diagnose or stage the condition
- Agreement to undergo CE-EBUS and no contraindications to EBUS-TBNA
- Good compliance and signed informed consent
You will not qualify if you...
- Known allergy to ultrasound contrast components
- Severe pulmonary hypertension with pulmonary artery pressure over 90 mmHg
- Angina pectoris, acute coronary syndrome, unstable ischemic heart disease, heart failure, cardiac dysfunction, or right-to-left cardiac shunting
- Uncontrolled essential hypertension
- Respiratory distress syndrome
- Pregnant or breastfeeding women
- Contraindications to bronchoscopy
- Any other conditions deemed unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo contrast-enhanced endobronchial ultrasound to observe pulmonary lesions and intrathoracic lymph nodes for diagnostic purposes.
1 procedure visit (in-person)
Long-term Monitoring
Duration - 6 months
Participants are monitored for diagnostic accuracy and outcomes over a 6-month period after the procedure.
Follow-up visits as scheduled over 6 months
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
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Research Team
J
Jiayuan sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Published Research Related To This Trial
Diagnostic Yield of CE-EBUS in Mediastinal and Hilar Lymphadenopathy: A Preliminary Study.
Ilaria Suriano, Luca Frasca, Filippo Longo...
https://pubmed.ncbi.nlm.nih.gov/40283633