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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University Third Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

(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.

Disqualifiers

(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.

Trial population

Patients with abnormal lymph nodes and who are scheduled for lymph nodes puncture or fine needle aspiration or surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

779 Participants
are divided into 2 treatment groups
Group A: benign lymph nodes1 intervention
Group B: malignant lymph nodes1 intervention

Trial outcomes

Primary outcomes

1

benign or malignant pathology results from biopsy or surgery

Time frame
within 1 month after SRUS imaging

Secondary outcomes

1

The expression level of various immuno-histochemical indicators of lymph nodes

Time frame
within 2 months after SRUS imaging
2

Microvascular Quantitative Indices between benign and malignant lymph nodes by SRUS

Time frame
within 2 months after the SRUS
3

Microvascular Quantitative Indices between lymph node metastasis and lymphoma

Time frame
within 2 months after the SRUS imaging
4

Blood supply mode of CEUS between benign and malignant lymph nodes

Time frame
within 2 months after the SRUS imaging

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.