LymphadenopathyNCT07155954
Value of Super-resolution Ultrasonography in Differentiating Benign and Malignant Lymph Nodes
An observational study of Lymphadenopathy and Lymphnode Metastasis, run by Peking University Third Hospital at 1 site in China.
Trial summary
Lymph nodes are one of the most important components of the human immune system, and superficial lymph node enlargement lacks specificity. Ultrasound examination has been widely used in the diagnosis of lymph node lesions and is of great significance in distinguishing between benign and malignant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphadenopathy, Lymphnode Metastasis, Lymphoma
- What is being tested?
- SRUS imaging of the lymph nodes before surgery or biopsy
- How many people
- 779 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2024to 22 Oct 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with abnormal lymph nodes and who are scheduled for lymph nodes puncture or fine needle aspiration or surgery
Who may be able to join
- (1)suggested abnormal lymph nodes indicated by ultrasonography; (2) Patients scheduled for lymph nodes puncture or fine needle aspiration or surgery; (3) Age greater than or equal to 18 years old.
Who cannot join
- (1) Pregnant and lactating women; (2)pathological results not indicating benign or malignant lymph nodes; (3) history of chemotherapy or radiotherapy ; (4) History of allergies to eggs, milk, and ultrasound contrast agents; (5) Patients with acute coronary syndrome, severe pulmonary hypertension, or acute respiratory distress syndrome.
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
Peking University Third Hospital
Beijing, Beijing Municipality, 100049
li gang cui, +86 13910627163, cuijuegang@126.com
About this study
Official title: Value of Super-resolution Ultrasound Microvascular Imaging in Distinguishing Benign and Malignant Superficial Lymph Nodes: a Prospective Multi-center Study
Lymph nodes are one of the most important components of the human immune system, and superficial lymph node enlargement lacks specificity.
Ultrasound examination has been widely used in the diagnosis of lymph node lesions and is of great significance in distinguishing between benign and malignant. However, the two-dimensional and Doppler ultrasound features of different types of lymph node lesions overlap and intersect, and the blood flow perfusion information of lymph nodes can provide more information for differentiation.
Read more
At present, the widely used contrast-enhanced ultrasound is easier to evaluate blood flow perfusion and can display small blood vessels smaller than 100 microns. The diagnostic accuracy of cervical lymph nodes using contrast-enhanced ultrasound is 80-90%.
However, current contrast-enhanced ultrasound is limited by physical diffraction, with a resolution ranging from sub-millimeter to millimeter. This limitation hinders the visualization of small blood vessels or microcirculation by ultrasound, and parameters such as vascular size, spatial vascular pattern, and velocity of microcirculation are crucial for disease diagnosis and prognosis evaluation. Super resolution ultrasound (SRUS) is a new blood flow imaging technique. By tracking the movement trajectory of micro-bubbles instead of imaging the micro-bubbles themselves, the ultrasound diffraction limit can be exceeded to improve the sensitivity and image resolution of blood flow.
Thus the study aim to evaluate the feasibility of SRUS technology in distinguishing between benign and malignant lymph nodes, and compare the differences in blood flow distribution and perfusion index between benign and malignant lymph nodes under SRUS imaging.
Read the detailed description
The study aim to evaluate the feasibility of SRUS technology in distinguishing between benign and malignant lymph nodes, and compare the differences in blood flow distribution, perfusion index, CEUS parameters, blood supply mode between benign and malignant lymph nodes under SRUS imaging.
- Being tested
- SRUS imaging of the lymph nodes before surgery or biopsy
- Medical subject headings
- Lymphadenopathy, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRUS imaging of the lymph nodes before surgery or biopsyDiagnostic test
Ultrasound contrast agent (Sonovue/Sonazoid) is administered to the patients through a peripheral vein. When the micro-bubbles enter the lymph nodes, super-resolution ultrasonography imaging will initiate immediately, to capture the trajectory of the micro-bubbles, thus construct a map of the microvascular distribution.
| Study group | Role | What they receive |
|---|---|---|
| benign lymph nodes | the lymph nodes are benign disease proved by pathology Receives: Diagnostic Test: SRUS imaging of the lymph nodes before surgery or biopsy | |
| malignant lymph nodes | lymph nodes are metastatic lymph nodes or lymphoma proved by pathology Receives: Diagnostic Test: SRUS imaging of the lymph nodes before surgery or biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
benign or malignant pathology results from biopsy or surgery
Measured: within 1 month after SRUS imaging
Secondary outcomes (5)
The expression level of various immuno-histochemical indicators of lymph nodes
Measured: within 2 months after SRUS imaging
Microvascular Quantitative Indices between benign and malignant lymph nodes by SRUS
Measured: within 2 months after the SRUS
Microvascular Quantitative Indices between lymph node metastasis and lymphoma
Measured: within 2 months after the SRUS imaging
Blood supply mode of CEUS between benign and malignant lymph nodes
Measured: within 2 months after the SRUS imaging
Quantitative analysis parameters of CEUS between benign and malignant lymph nodes
Quantitative analysis parameters of CEUS including AT, TTP, PKI, MTT, and AUC between benign and malignant lymph nodes
Measured: within 2 months after SRUS imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start23 Oct 2024
- Primary completion22 Oct 2027 (estimated)
- Study completion22 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphadenopathyStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 779 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- li g cui, Chief Physician, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155954
- Sponsor's protocol ID
- M2024853
- Status last verified
- Feb 2025
- First submitted
- 7 Apr 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Super-resolution Ultrasound Microvascular Imaging in Distinguishing Benign and Malignant Superficial Lymph Nodes: a Prospective Multi-center Study
- ClinicalTrials.gov ID
- NCT07155954
- Acronym / sponsor ID
- M2024853
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 779 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 22 Oct 2027 (estimated)
- Study completion
- 22 Oct 2027 (estimated)
- First posted
- 4 Sep 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.
Lymph nodes are one of the most important components of the human immune system, and superficial lymph node enlargement lacks specificity.
Ultrasound examination has been widely used in the diagnosis of lymph node lesions and is of great significance in distinguishing between benign and malignant. However, the two-dimensional and Doppler ultrasound features of different types of lymph node lesions overlap and intersect, and the blood flow perfusion information of lymph nodes can provide more information for differentiation.
At present, the widely used contrast-enhanced ultrasound is easier to evaluate blood flow perfusion and can display small blood vessels smaller than 100 microns. The diagnostic accuracy of cervical lymph nodes using contrast-enhanced ultrasound is 80-90%.
However, current contrast-enhanced ultrasound is limited by physical diffraction, with a resolution ranging from sub-millimeter to millimeter. This limitation hinders the visualization of small blood vessels or microcirculation by ultrasound, and parameters such as vascular size, spatial vascular pattern, and velocity of microcirculation are crucial for disease diagnosis and prognosis evaluation. Super resolution ultrasound (SRUS) is a new blood flow imaging technique. By tracking the movement trajectory of micro-bubbles instead of imaging the micro-bubbles themselves, the ultrasound diffraction limit can be exceeded to improve the sensitivity and image resolution of blood flow.
Thus the study aim to evaluate the feasibility of SRUS technology in distinguishing between benign and malignant lymph nodes, and compare the differences in blood flow distribution and perfusion index between benign and malignant lymph nodes under SRUS imaging.
Detailed description
The study aim to evaluate the feasibility of SRUS technology in distinguishing between benign and malignant lymph nodes, and compare the differences in blood flow distribution, perfusion index, CEUS parameters, blood supply mode between benign and malignant lymph nodes under SRUS imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| benign lymph nodes | – | Diagnostic Test: SRUS imaging of the lymph nodes before surgery or biopsythe lymph nodes are benign disease proved by pathology |
| malignant lymph nodes | – | Diagnostic Test: SRUS imaging of the lymph nodes before surgery or biopsylymph nodes are metastatic lymph nodes or lymphoma proved by pathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with abnormal lymph nodes and who are scheduled for lymph nodes puncture or fine needle aspiration or surgery
Key inclusion criteria (1 listed)
- (1)suggested abnormal lymph nodes indicated by ultrasonography; (2) Patients scheduled for lymph nodes puncture or fine needle aspiration or surgery; (3) Age greater than or equal to 18 years old.
Key exclusion criteria (1 listed)
- (1) Pregnant and lactating women; (2)pathological results not indicating benign or malignant lymph nodes; (3) history of chemotherapy or radiotherapy ; (4) History of allergies to eggs, milk, and ultrasound contrast agents; (5) Patients with acute coronary syndrome, severe pulmonary hypertension, or acute respiratory distress syndrome.
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 |
|---|---|---|
| SRUS imaging of the lymph nodes before surgery or biopsyUltrasound contrast agent (Sonovue/Sonazoid) is administered to the patients through a peripheral vein. When the micro-bubbles enter the lymph nodes, super-resolution ultrasonography imaging will initiate immediately, to capture the trajectory of the micro-bubbles, thus construct a map of the microvascular distribution. | Diagnostic test | benign lymph nodes, malignant lymph nodes |
Primary outcome
benign or malignant pathology results from biopsy or surgery
Time frame: within 1 month after SRUS imaging
5 secondary outcomes
The expression level of various immuno-histochemical indicators of lymph nodes
Time frame: within 2 months after SRUS imaging
Microvascular Quantitative Indices between benign and malignant lymph nodes by SRUS
Time frame: within 2 months after the SRUS
Microvascular Quantitative Indices between lymph node metastasis and lymphoma
Time frame: within 2 months after the SRUS imaging
Blood supply mode of CEUS between benign and malignant lymph nodes
Time frame: within 2 months after the SRUS imaging
Quantitative analysis parameters of CEUS between benign and malignant lymph nodes
Time frame: within 2 months after SRUS imaging
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 4 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
li g cui, Chief Physician study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphadenopathy and Lymphnode Metastasis, run by Peking University Third 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 1 inclusion and 1 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 4 Sep 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 li g cui (+86 13910627163, cuijuegang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
benign or malignant pathology results from biopsy or surgery (time frame: within 1 month after SRUS imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2025.