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

May 4, 2026 updated by: Nathalie Sarup Panduro, Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Rigshospitalet
      • Kongens Lyngby, Capital Region, Denmark, 2800
        • Technical University of Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Controls
Healthy participants
Cases
Patients with malignant lymph nodes on the neck
Other: Malignant lymph nodes
Patients with a condition; either lymphoma on the neck or head and neck cancer with lymph node metastases on the neck.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Super-resolution ultrasound image of normal and malignant human lymph nodes
Time Frame: 1 minute
With super-resolution ultrasound imaging, the investigators will visualize the microvasculature in the lymph nodes.
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vessel distribution
Time Frame: 1 minute
Visual distribution of the nodal microvasculature
1 minute
Microvessel density
Time Frame: 1 minute
The ratio of the vessel volume to the full volume in different regions
1 minute
Flow velocity
Time Frame: 1 minute
In mm/s
1 minute
Vessel diameter
Time Frame: 1 min
micrometer
1 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

University of Copenhagen
Technical University of Denmark

Investigators

  • Principal Investigator: Nathalie Sarup Panduro, MD, The Department of Diagnostic Radiology, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2022

Primary Completion (Actual)

April 1, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SURE-LN-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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