An observational study in Lymphadenopathy, Lymphnode Metastasis and Lymphoma, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Peking University Third Hospital · Observational
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.
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.
77 studies on the registry are indexed under Lymphadenopathy; 14 are open to participants now.
This study's planned enrollment of 779 is above the median of 139 across 22 observational studies indexed under Lymphadenopathy.
Browse Lymphadenopathy studies →Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
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Patients with abnormal lymph nodes and who are scheduled for lymph nodes puncture or fine needle aspiration or surgery
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Exclusion Criteria:
the lymph nodes are benign disease proved by pathology
Diagnostic Test: SRUS imaging of the lymph nodes before surgery or biopsy
lymph nodes are metastatic lymph nodes or lymphoma proved by pathology
Diagnostic Test: SRUS 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.
benign or malignant pathology results from biopsy or surgery
Time frame: within 1 month after SRUS imaging
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
Quantitative analysis parameters of CEUS including AT, TTP, PKI, MTT, and AUC between benign and malignant lymph nodes
Time frame: within 2 months after SRUS imaging
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Oct 2027, 35 months after the start.
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