Super-resolution ultrasound to distinguish benign from malignant lymph nodes
Value of Super-resolution Ultrasound Microvascular Imaging in Distinguishing Benign and Malignant Superficial Lymph Nodes: a Prospective Multi-center Study
This project tries super-resolution ultrasound to see if it can tell whether enlarged lymph nodes are benign or cancerous in adults who are scheduled for lymph node biopsy or surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 779 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07155954 on ClinicalTrials.gov |
What this trial studies
This observational study uses super-resolution ultrasonography (SRUS) and contrast-enhanced ultrasound (CEUS) to image superficial lymph nodes before biopsy or surgery. Investigators will compare blood flow distribution, perfusion indices, CEUS parameters, and blood supply patterns on SRUS between nodes later confirmed as benign or malignant by pathology. Adults with ultrasound-suspected abnormal lymph nodes who are scheduled for puncture, fine needle aspiration, or surgery are eligible, while pregnant people, those with prior chemo/radiation, contrast allergies, or severe cardiopulmonary disease are excluded. Imaging findings will be correlated with histopathology to determine whether SRUS adds diagnostic value over conventional CEUS.
Who should consider this trial
Good fit: Adults (≥18 years) with superficially enlarged lymph nodes identified on ultrasound who are scheduled for lymph node biopsy, fine needle aspiration, or surgery and who have no contraindication to ultrasound contrast are ideal candidates.
Not a fit: Patients who are pregnant or lactating, have had prior chemotherapy or radiotherapy, have allergies to contrast agents or egg/milk, or have severe cardiopulmonary conditions are unlikely to participate or benefit from this imaging approach.
Why it matters
Potential benefit: If successful, SRUS could improve noninvasive differentiation of benign and malignant lymph nodes and help reduce unnecessary biopsies or guide surgical planning.
How similar studies have performed: Contrast-enhanced ultrasound has shown 80–90% diagnostic accuracy for cervical lymph nodes, but applying super-resolution ultrasound to this question is relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: li g cui
- Email: cuijuegang@126.com
- Phone: +86 13910627163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.