Clinical trial · Observational
SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph Nodes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Malignant lymph nodes | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Controls
- description
- Healthy participants
- label
- Cases
- description
- Patients with malignant lymph nodes on the neck
- interventionNames
- Other: Malignant lymph nodes
Primary outcomes (1)
- measure
- Super-resolution ultrasound image of normal and malignant human lymph nodes
- timeFrame
- 1 minute
- description
- With super-resolution ultrasound imaging, the investigators will visualize the microvasculature in the lymph nodes.
Secondary outcomes (4)
- measure
- Vessel distribution
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (36)
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- BACKGROUNDAhuja 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. PMID 11247696
- BACKGROUNDAndersen 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. PMID 33105888
- BACKGROUNDAykan 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. PMID 32133275
- BACKGROUNDBasile 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. PMID 11592947
- BACKGROUNDBeckman 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. PMID 31280589
- BACKGROUNDBrown 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.