Lung LesionsNCT07060378
A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes
A study testing Contrast-enhanced endobronchial ultrasound in people with Lung Lesions and Mediastinal and Hilar Lymph Node Enlargement, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
Exploring the Clinical Application Value of Contrast Enhancement Features in CE-EBUS Images for the Diagnosis of Pulmonary Lesions and Intrapulmonary Lymph Nodes Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Lesions, Mediastinal and Hilar Lymph Node Enlargement
- What is being tested?
- Contrast-enhanced endobronchial ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
jiayuan sun, +1511 86-021-22200000, jysun1976@163.com
About this study
Exploring the Clinical Application Value of Contrast Enhancement Features in CE-EBUS Images for the Diagnosis of Pulmonary Lesions and Intrapulmonary Lymph Nodes
- Being tested
- Contrast-enhanced endobronchial ultrasound
- Keywords
- CE-EBUS, Ultrasound Contrast Agent, Microbubbles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced endobronchial ultrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Contrast-Enhanced Endobronchial Ultrasound | Experimental | Not described Receives: Device: Contrast-enhanced endobronchial ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Sensitivity is defined as the number of lesions correctly identified as malignant using the CE-EBUS interpretation criteria divided by the total number of malignant lesions.
Specificity is defined as the number of lesions correctly identified as benign using the CE-EBUS interpretation criteria divided by the total number of benign lesions.
Positive predictive value is the percentage of truly malignant lesions among all lesions identified as malignant using the CE-EBUS interpretive criteria.
Negative predictive value is the percentage of truly benign lesions among all lesions identified as benign using CE-EBUS interpretive criteria.
Measured: 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
Sensitivity is defined as the number of lesions correctly identified as malignant using the CE-EBUS interpretation criteria divided by the total number of malignant lesions.
Specificity is defined as the number of lesions correctly identified as benign using the CE-EBUS interpretation criteria divided by the total number of benign lesions.
Positive predictive value is the percentage of truly malignant lesions among all lesions identified as malignant using the CE-EBUS interpretive criteria.
Negative predictive value is the percentage of truly benign lesions among all lesions identified as benign using CE-EBUS interpretive criteria.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start10 Jul 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung LesionsStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Contrast-Enhanced Endobronchial Ultrasound
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060378
- Sponsor's protocol ID
- KS25026
- Status last verified
- May 2025
- First submitted
- 22 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37813701Suriano 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.
PubMed 40283633
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes
- ClinicalTrials.gov ID
- NCT07060378
- Acronym / sponsor ID
- KS25026
- Keywords
- CE-EBUS, Ultrasound Contrast Agent, Microbubbles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exploring the Clinical Application Value of Contrast Enhancement Features in CE-EBUS Images for the Diagnosis of Pulmonary Lesions and Intrapulmonary Lymph Nodes
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Contrast-Enhanced Endobronchial Ultrasound
| Arm | Type | Receives |
|---|---|---|
| Contrast-Enhanced Endobronchial Ultrasound | Experimental | Device: Contrast-enhanced endobronchial ultrasound |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced endobronchial ultrasoundUsing 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. | Device | Contrast-Enhanced Endobronchial Ultrasound |
Primary outcome
Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy
Time frame: 6 month post-procedure
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.
Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrapulmonary lesions
Time frame: 6 month post-procedure
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 37813701McGrath 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.
- Results publication: PubMed 40283633Suriano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced endobronchial ultrasound in people with Lung Lesions and Mediastinal and Hilar Lymph Node Enlargement, run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan sun (+1511 86-021-22200000, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy (time frame: 6 month post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07060378, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.