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SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph Nodes

SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph Nodes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05754814
Enrollment
20
Registered
2023-03-06
Start date
2022-06-28
Completion date
2026-04-01
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Lymph Node Metastasis, Lymphoma

Keywords

head and neck cancer, lymphoma, lymph node metastasis, super-resolution ultrasound, microvasculature

Brief summary

The goal of this observational study is to visualize the small vessels in normal and cancerous lymph nodes on the neck with a new ultrasound technique. The main questions it aims to answer are: * Is it possible to visualize the network of the smallest vessels in lymph nodes on the neck? * Is it possible to distinguish between healthy and cancerous lymph nodes using different parameters? The participants will have 1 lymph nodes ultrasound scanned with a standard ultrasound technique and the new technique.

Detailed description

Super-resolution ultrasound using erythrocytes (SURE) is a new ultrasound technique for visualizing the very small blood vessels in the body. The technique uses tracking of the blood's red blood cells (erythrocytes) to achieve a higher resolution of the blood vessels' shape, structure, and blood flow. The technique makes it possible to create images with much higher resolution than normal ultrasound, which means that even very small blood vessels can be imaged and measured. In many diseases, the small blood vessels change their function or structure. One of the major disease groups where SURE has significant potential is cancer. In cancerous nodes, the small blood vessels change: they become twisted, irregular, and function poorly. If changes in the small vessels can be detected at an early stage using SURE, it can lead to quicker diagnoses and better evaluations of the effectiveness of treatment. In this study, the investigators aim to demonstrate the practical feasibility of SURE imaging in human lymph nodes and investigate the clinical relevance of SURE imaging in the diagnosis of malignant lymph nodes by comparing lymph nodes from healthy participants with lymph nodes from participants with head and neck cancer metastases or lymphoma.

Interventions

Patients with a condition; either lymphoma on the neck or head and neck cancer with lymph node metastases on the neck.

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER
Technical University of Denmark
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Participants must be 18 years or older, at the time of signing the informed consent * Participants who can lie still for 1 minute * Capable of giving signed informed consent Inclusion criteria for healthy participants: * Participants who are overtly healthy as determined by medical history * Participants who have a superficial lymph node laterally on the neck with a normal appearance on standard B-mode ultrasound available for SURE imaging Inclusion criteria for participants with head and neck cancer or lymphoma: * Participants who, besides their untreated head and neck cancer or lymphoma, are overtly healthy as determined by medical evaluation and medical history * Participants with lymphoma or head and neck cancer and lymph node metastasis verified by a biopsy or surgical excision. * Participants who have superficial lymph nodes laterally on the neck

Exclusion criteria

* Pregnancy * Dementia * Physique making ultrasound scanning difficult * Ongoing or recent (within the last 4 weeks) infectious disease (bacterial, viral, fungal, or protozoal) which may give rise to reactive lymph nodes * Diseases that cause lymphadenopathy: Some chronic infectious diseases (HIV, Tuberculosis, Hepatitis B), Systemic diseases (rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, other rare systemic diseases\*), Primary adrenal insufficiency (Addison´s disease), Leukemia, Lymphoma or other cancers (besides the type of cancer the participant is being examined for at the Department of Otorhinolaryngology, Head and Neck Surgery \& Audiology, Rigshospitalet) * Drugs that cause lymphadenopathy: Antibiotics (Cephalosporins, Penicillin, Sulfonamides), Antiepileptics (Carbamazepine, Ethosuximide, Lamotrigine, Phenytoin, Primidone), Antihypertensives (Atenolol, Captopril, Hydralazine), Other (Allopurinol, Imatinib) * Castleman's disease, Kikuchi's disease, Kawasaki disease, Inflammatory pseudotumor, Amyloidosis, Kimura disease, Rosai-Dorfman disease, IgG4-related disease, Still's disease, dermatomyositis, Churg-Strauss, histiocytosis, chronic granulomatous diseases, Autoimmune lymphoproliferative syndrome, lipid storage diseases.

Design outcomes

Primary

MeasureTime frameDescription
Super-resolution ultrasound image of normal and malignant human lymph nodes1 minuteWith super-resolution ultrasound imaging, the investigators will visualize the microvasculature in the lymph nodes.

Secondary

MeasureTime frameDescription
Vessel distribution1 minuteVisual distribution of the nodal microvasculature
Microvessel density1 minuteThe ratio of the vessel volume to the full volume in different regions
Flow velocity1 minuteIn mm/s
Vessel diameter1 minmicrometer

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORNathalie Sarup Panduro, MD

The Department of Diagnostic Radiology, Rigshospitalet

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026