RecruitingNCT05754814

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


Sponsor

Rigshospitalet, Denmark

Enrollment

100 participants

Start Date

Jun 28, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria9

  • 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

Exclusion Criteria7

  • 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.

Interventions

OTHERMalignant lymph nodes

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


Locations(2)

Rigshospitalet

Copenhagen, Capital Region, Denmark

Technical University of Denmark

Kongens Lyngby, Capital Region, Denmark

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NCT05754814


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