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

P

Peking University

Status

Enrolling

Conditions

Lymphatic Tuberculosis
Lymphoma
Lymphnode Metastasis
Lymphadenopathy

Treatments

Diagnostic Test: SRUS imaging of the lymph nodes before surgery or biopsy

Study type

Observational

Funder types

Other

Identifiers

NCT07155954
M2024853

Details and patient eligibility

About

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.

Full 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.

Enrollment

779 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

779 participants in 2 patient groups

benign lymph nodes
Description:
the lymph nodes are benign disease proved by pathology
Treatment:
Diagnostic Test: SRUS imaging of the lymph nodes before surgery or biopsy
malignant lymph nodes
Description:
lymph nodes are metastatic lymph nodes or lymphoma proved by pathology
Treatment:
Diagnostic Test: SRUS imaging of the lymph nodes before surgery or biopsy

Trial contacts and locations

1

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Central trial contact

li g cui

Data sourced from clinicaltrials.gov

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