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

Recruiting

• Conditions: Lymphadenopathy; Lymphnode Metastasis; Lymphoma; Lymphatic Tuberculosis

• Registration Number: NCT07155954
• Lead Sponsor: Peking University Third Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2024-10-23
• Status Verified: 2025-02
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2027-10-22
• Study Completion: 2027-10-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 779

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
benign or malignant pathology results from biopsy or surgery	within 1 month after SRUS imaging

Secondary Outcome Measures

Name	Time	Method
Microvascular Quantitative Indices between benign and malignant lymph nodes by SRUS	within 2 months after the SRUS
The expression level of various immuno-histochemical indicators of lymph nodes	within 2 months after SRUS imaging
Blood supply mode of CEUS between benign and malignant lymph nodes	within 2 months after the SRUS imaging
Microvascular Quantitative Indices between lymph node metastasis and lymphoma	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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing Municipality, China