Trial Title:
SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph Nodes
NCT ID:
NCT05754814
Condition:
Head and Neck Cancer
Lymphoma
Lymph Node Metastasis
Conditions: Official terms:
Neoplasm Metastasis
Head and Neck Neoplasms
Lymphatic Metastasis
Conditions: Keywords:
head and neck cancer
lymphoma
lymph node metastasis
super-resolution ultrasound
microvasculature
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Malignant lymph nodes
Description:
Patients with a condition; either lymphoma on the neck or head and neck cancer with lymph
node metastases on the neck.
Arm group label:
Cases
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
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 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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Nathalie Sarup Panduro, MD
Phone:
+4529273193
Email:
nathalie04@gmail.com
Contact backup:
Last name:
Michael Bachmann Nielsen, Prof. PhD
Phone:
+4535458233
Email:
mbn@dadlnet.dk
Facility:
Name:
Technical University of Denmark
Address:
City:
Lyngby
Zip:
2800
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Nathalie Sarup Panduro, MD
Phone:
+4529273193
Email:
nathalie04@gmail.com
Contact backup:
Last name:
Jørgen Arendt Jensen, Prof. PhD
Phone:
+4545253924
Email:
jaje@dtu.dk
Start date:
June 28, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Collaborator:
Agency:
Technical University of Denmark
Agency class:
Other
Collaborator:
Agency:
University of Copenhagen
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05754814
