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

NCT07155954 | Recruiting

• 1 other identifier: M2024853
• Study Type: observational
• Target: 779
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphadenopathy; Lymphnode Metastasis; Lymphoma; Lymphatic Tuberculosis

Outcome Measures

Primary Outcomes (1)

• benign or malignant pathology results from biopsy or surgery

  within 1 month after SRUS imaging

Secondary Outcomes (5)

• 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

Study Arms (2)

benign lymph nodes

the lymph nodes are benign disease proved by pathology

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

malignant lymph nodes

lymph nodes are metastatic lymph nodes or lymphoma proved by pathology

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

Interventions

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.

benign lymph nodes; malignant lymph nodes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100049, China

RECRUITING

MeSH Terms

Conditions

Lymphadenopathy; Lymphoma

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• li g cui, Chief Physician

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

li g cui

CONTACT

+86 13910627163; cuijuegang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: September 4, 2025
• Study Start: October 23, 2024
• Primary Completion (Estimated): October 22, 2027
• Study Completion (Estimated): October 22, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-02

Locations

CN (1)