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NCT Number: NCT07155954

Value of Super-resolution Ultrasonography in Differentiating Benign and Malignant Lymph Nodes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100049, China

Location status: Recruiting

Location contact

li gang cui

CONTACT

[email protected]

+86 13910627163

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Treatment and study plan

SRUS imaging of the lymph nodes before surgery or biopsy

Diagnostic 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.

Primary outcomes

  1. benign or malignant pathology results from biopsy or surgery

    Time frame: within 1 month after SRUS imaging

Secondary outcomes

  1. The expression level of various immuno-histochemical indicators of lymph nodes

    Time frame: within 2 months after SRUS imaging

  2. Microvascular Quantitative Indices between benign and malignant lymph nodes by SRUS

    Time frame: within 2 months after the SRUS

  3. Microvascular Quantitative Indices between lymph node metastasis and lymphoma

    Time frame: within 2 months after the SRUS imaging

  4. Blood supply mode of CEUS between benign and malignant lymph nodes

    Time frame: within 2 months after the SRUS imaging

  5. Quantitative analysis parameters of CEUS between benign and malignant lymph nodes

    Time frame: within 2 months after SRUS imaging

    Quantitative analysis parameters of CEUS including AT, TTP, PKI, MTT, and AUC between benign and malignant lymph nodes

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Value of Super-resolution Ultrasound Microvascular Imaging in Distinguishing Benign and Malignant Superficial Lymph Nodes: a Prospective Multi-center Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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