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Head and Neck CancerNCT05754814

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

An observational study of Head and Neck Cancer and Lymphoma, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Malignant lymph nodes
How many people
20 participants
Where
2 sitesDenmark
Study dates
28 Jun 2022to 1 Apr 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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
  • 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:
Show all 9Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites
  • Rigshospitalet

    Copenhagen, Capital Region, 2100

  • Technical University of Denmark

    Kongens Lyngby, Capital Region, 2800

Other trials in Denmark

About this study

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.

Read the 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.

Being tested
Malignant lymph nodes
Keywords
head and neck cancer, lymphoma, lymph node metastasis, super-resolution ultrasound, microvasculature
Medical subject headings
Head and Neck Neoplasms, Lymphoma, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Malignant lymph nodesOther

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

Study groups in NCT05754814
Study groupRoleWhat they receive
ControlsHealthy participants
CasesPatients with malignant lymph nodes on the neck
Receives: Other: Malignant lymph nodes

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 minute

Secondary outcomes (4)
  1. Vessel distribution

    Visual distribution of the nodal microvasculature

    Measured: 1 minute

  2. Microvessel density

    The ratio of the vessel volume to the full volume in different regions

    Measured: 1 minute

  3. Flow velocity

    In mm/s

    Measured: 1 minute

  4. Vessel diameter

    micrometer

    Measured: 1 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start28 Jun 2022
  3. Primary completion1 Apr 2026
  4. Study completion1 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05754814
Sponsor's protocol ID
SURE-LN-2022
Status last verified
May 2026
First submitted
26 Jan 2023
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Abdeyrim A, He S, Zhang Y, Mamtali G, Asla A, Yusup M, Liu J. Prognostic value of lymph node ratio in laryngeal and hypopharyngeal squamous cell carcinoma: a systematic review and meta-analysis. J Otolaryngol Head Neck Surg. 2020 May 29;49(1):31. doi: 10.1186/s40463-020-00421-w.

    PubMed 32471483
  • Ahuja AT, Ying M, Ho SS, Metreweli C. Distribution of intranodal vessels in differentiating benign from metastatic neck nodes. Clin Radiol. 2001 Mar;56(3):197-201. doi: 10.1053/crad.2000.0574.

    PubMed 11247696
  • Andersen SB, Taghavi I, Hoyos CAV, Sogaard SB, Gran F, Lonn L, Hansen KL, Jensen JA, Nielsen MB, Sorensen CM. Super-Resolution Imaging with Ultrasound for Visualization of the Renal Microvasculature in Rats Before and After Renal Ischemia: A Pilot Study. Diagnostics (Basel). 2020 Oct 22;10(11):862. doi: 10.3390/diagnostics10110862.

    PubMed 33105888
  • Aykan NF, Ozatli T. Objective response rate assessment in oncology: Current situation and future expectations. World J Clin Oncol. 2020 Feb 24;11(2):53-73. doi: 10.5306/wjco.v11.i2.53.

    PubMed 32133275
  • Basile DP, Donohoe D, Roethe K, Osborn JL. Renal ischemic injury results in permanent damage to peritubular capillaries and influences long-term function. Am J Physiol Renal Physiol. 2001 Nov;281(5):F887-99. doi: 10.1152/ajprenal.2001.281.5.F887.

    PubMed 11592947
  • Beckman JA, Duncan MS, Damrauer SM, Wells QS, Barnett JV, Wasserman DH, Bedimo RJ, Butt AA, Marconi VC, Sico JJ, Tindle HA, Bonaca MP, Aday AW, Freiberg MS. Microvascular Disease, Peripheral Artery Disease, and Amputation. Circulation. 2019 Aug 6;140(6):449-458. doi: 10.1161/CIRCULATIONAHA.119.040672. Epub 2019 Jul 8.

    PubMed 31280589
  • Brown M, Assen FP, Leithner A, Abe J, Schachner H, Asfour G, Bago-Horvath Z, Stein JV, Uhrin P, Sixt M, Kerjaschki D. Lymph node blood vessels provide exit routes for metastatic tumor cell dissemination in mice. Science. 2018 Mar 23;359(6382):1408-1411. doi: 10.1126/science.aal3662.

    PubMed 29567714
  • Chen Q, Yu J, Rush BM, Stocker SD, Tan RJ, Kim K. Ultrasound super-resolution imaging provides a noninvasive assessment of renal microvasculature changes during mouse acute kidney injury. Kidney Int. 2020 Aug;98(2):355-365. doi: 10.1016/j.kint.2020.02.011. Epub 2020 Mar 3.

    PubMed 32600826
  • Christensen-Jeffries K, Browning RJ, Tang MX, Dunsby C, Eckersley RJ. In vivo acoustic super-resolution and super-resolved velocity mapping using microbubbles. IEEE Trans Med Imaging. 2015 Feb;34(2):433-40. doi: 10.1109/TMI.2014.2359650. Epub 2014 Sep 23.

    PubMed 25265604
  • Christensen-Jeffries K, Couture O, Dayton PA, Eldar YC, Hynynen K, Kiessling F, O'Reilly M, Pinton GF, Schmitz G, Tang MX, Tanter M, van Sloun RJG. Super-resolution Ultrasound Imaging. Ultrasound Med Biol. 2020 Apr;46(4):865-891. doi: 10.1016/j.ultrasmedbio.2019.11.013. Epub 2020 Jan 21.

    PubMed 31973952
  • Corliss BA, Mathews C, Doty R, Rohde G, Peirce SM. Methods to label, image, and analyze the complex structural architectures of microvascular networks. Microcirculation. 2019 Jul;26(5):e12520. doi: 10.1111/micc.12520. Epub 2019 Jan 17.

    PubMed 30548558
  • Demene C, Robin J, Dizeux A, Heiles B, Pernot M, Tanter M, Perren F. Transcranial ultrafast ultrasound localization microscopy of brain vasculature in patients. Nat Biomed Eng. 2021 Mar;5(3):219-228. doi: 10.1038/s41551-021-00697-x. Epub 2021 Mar 15.

    PubMed 33723412
  • Demidov V, Maeda A, Sugita M, Madge V, Sadanand S, Flueraru C, Vitkin IA. Preclinical longitudinal imaging of tumor microvascular radiobiological response with functional optical coherence tomography. Sci Rep. 2018 Jan 8;8(1):38. doi: 10.1038/s41598-017-18635-w.

    PubMed 29311686
  • Dencks S, Piepenbrock M, Opacic T, Krauspe B, Stickeler E, Kiessling F, Schmitz G. Clinical Pilot Application of Super-Resolution US Imaging in Breast Cancer. IEEE Trans Ultrason Ferroelectr Freq Control. 2019 Mar;66(3):517-526. doi: 10.1109/TUFFC.2018.2872067. Epub 2018 Sep 24.

    PubMed 30273150
  • Ehling J, Theek B, Gremse F, Baetke S, Mockel D, Maynard J, Ricketts SA, Grull H, Neeman M, Knuechel R, Lederle W, Kiessling F, Lammers T. Micro-CT imaging of tumor angiogenesis: quantitative measures describing micromorphology and vascularization. Am J Pathol. 2014 Feb;184(2):431-41. doi: 10.1016/j.ajpath.2013.10.014. Epub 2013 Nov 18.

    PubMed 24262753

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Cancer and Lymphoma, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Super-resolution ultrasound image of normal and malignant human lymph nodes (time frame: 1 minute). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05754814, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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