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Recruiting NCT07155954

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

— Observational Lymphadenopathy Lymphnode Metastasis Lymphoma Lymphatic Tuberculosis

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What is being studied
The protocol lists: SRUS imaging of the lymph nodes before surgery or biopsy.
Who it may be relevant to
Registry conditions: Lymphadenopathy, Lymphnode Metastasis, Lymphoma, Lymphatic Tuberculosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • benign or malignant pathology results from biopsy or surgery [Time frame: within 1 month after SRUS imaging]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking University Third Hospital — Beijing

Identifiers

NCT: NCT07155954 · M2024853

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗