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

NCT05754814 | Recruiting

• 1 other identifier: SURE-LN-2022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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 1-2 lymph nodes ultrasound scanned with a standard ultrasound technique and the new technique.

Conditions

Head and Neck Cancer; Lymphoma; Lymph Node Metastasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Super-resolution ultrasound image of normal and malignant human lymph nodes

  With super-resolution ultrasound imaging, the investigators will visualize the microvasculature in the lymph nodes.

  1 minute

Secondary Outcomes (3)

• Vessel distribution

  1 minute

• Microvessel density

  1 minute

• Flow velocity

  1 minute

Study Arms (2)

Controls

Healthy participants

Cases

Patients with malignant lymph nodes on the neck

Other: Malignant lymph nodes

Interventions

Malignant lymph nodes OTHER

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

Cases

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The healthy participants are recruited via forsøgsperson.dk and www.sundhed.dk/borger/behandling-ogrettigheder/bliv-forsoegsperson as well as via advertising posters at Rigshospitalet and at the Technical University of Denmark and possibly on social media. The participants will be recruited among the patients with head and neck cancer metastases or lymphoma currently referred for a fast-track program at the Department of Otorhinolaryngology, Head and Neck Surgery \& Audiology, Rigshospitalet.

You may qualify if:

• Participants must be 18 to 70 years of age, at the time of signing the informed consent
• Participants who can lie still for 1 minute
• Capable of giving signed informed consent
• 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
• Participants who, besides their untreated head and neck cancer or lymphoma, are overtly healthy as determined by medical evaluation and medical history
• Participants with untreated lymphoma or head and neck cancer and lymph node metastasis verified by a biopsy.
• Participants who have superficial lymph nodes laterally on the neck up to 2.5 cm (so the entire lymph node is in the SURE image)
• Participants who will have their lymph nodes surgically removed

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Technical University of Denmark: collaborator
• University of Copenhagen: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Technical University of Denmark

Kongens Lyngby, Capital Region, 2800, Denmark

RECRUITING

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MeSH Terms

Conditions

Head and Neck Neoplasms; Lymphoma; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathalie Sarup Panduro, MD

  The Department of Diagnostic Radiology, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Sarup Panduro, MD

CONTACT

+4529273193; nathalie04@gmail.com

Michael Bachmann Nielsen, Prof. Phd

CONTACT

+4535458233; mbn@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 6, 2023
• Study Start: June 28, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

DK (2)