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

NCT07155954 — Recruiting, 779 participants, Peking University Third Hospital
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Value of Super-resolution Ultrasound Microvascular Imaging in Distinguishing Benign and Malignant Superficial Lymph Nodes: a Prospective Multi-center Study

RegistryNCT07155954
StatusRecruiting
Study typeObservational
Enrollment779 (Estimated)
SponsorPeking University Third Hospital (Other)
ConditionsLymphadenopathy, Lymphnode Metastasis, Lymphoma, Lymphatic Tuberculosis
InterventionsSRUS imaging of the lymph nodes before surgery or biopsy (Diagnostic test)
Datesstart 2024-10-23, primary completion 2027-10-22 (estimated), completion 2027-10-22 (estimated), first posted 2025-09-04, last updated 2025-09-04
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Lymphadenopathy All trials for Lymphnode Metastasis All trials of SRUS imaging of the lymph nodes before surgery or biopsy

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
benign lymph nodesDiagnostic Test: SRUS imaging of the lymph nodes before surgery or biopsythe lymph nodes are benign disease proved by pathology
malignant lymph nodesDiagnostic Test: SRUS imaging of the lymph nodes before surgery or biopsylymph nodes are metastatic lymph nodes or lymphoma proved by pathology
  • 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.

+Outcome measures

Primary outcomes

  • benign or malignant pathology results from biopsy or surgery [within 1 month after SRUS imaging]

Secondary outcomes

  • The expression level of various immuno-histochemical indicators of lymph nodes [within 2 months after SRUS imaging]
  • Microvascular Quantitative Indices between benign and malignant lymph nodes by SRUS [within 2 months after the SRUS]
  • Microvascular Quantitative Indices between lymph node metastasis and lymphoma [within 2 months after the SRUS imaging]
  • Blood supply mode of CEUS between benign and malignant lymph nodes [within 2 months after the SRUS imaging]
  • Quantitative analysis parameters of CEUS between benign and malignant lymph nodes [within 2 months after SRUS imaging]: Quantitative analysis parameters of CEUS including AT, TTP, PKI, MTT, and AUC between benign and malignant lymph nodes

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Peking University Third HospitalBeijing, Beijing MunicipalityChinaRecruiting

+Investigators

  • li g cui, Chief Physician, Study chair, Peking University Third Hospital