RecruitingNCT07155954

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

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


Sponsor

Peking University Third Hospital

Enrollment

779 participants

Start Date

Oct 23, 2024

Study Type

OBSERVATIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a newer, high-definition ultrasound technique called super-resolution ultrasonography can tell the difference between cancerous and non-cancerous lymph nodes more accurately than standard imaging methods. **You may be eligible if...** - You are 18 or older - An ultrasound has shown you have abnormal lymph nodes - You are scheduled for a lymph node biopsy, fine needle aspiration, or surgery **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your biopsy result does not clearly indicate whether the lymph node is benign or malignant - You have received chemotherapy or radiation in the past - You have allergies to eggs, milk, or ultrasound contrast agents - You have acute coronary syndrome (heart attack), severe pulmonary hypertension, or acute respiratory distress Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTSRUS imaging of the lymph nodes before surgery or biopsy

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.


Locations(1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

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NCT07155954


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