SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph Nodes (NCT05754814) | Clinical Trial Compass
CompletedNot Applicable
SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph Nodes
Denmark20 participantsStarted 2022-06-28
Plain-language 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 lymph nodes ultrasound scanned with a standard ultrasound technique and the new technique.
Who can participate
Age range18 Years
SexALL
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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 ex…
What they're measuring
1
Super-resolution ultrasound image of normal and malignant human lymph nodes