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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754814
• Other study ID #: SURE-LN-2022
• Status: Recruiting
• Start date: June 28, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: Nathalie Sarup Panduro, MD
• Phone: +4529273193
• Email: nathalie04[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lymph Node Metastasis
• Lymphatic Metastasis
• Lymphoma
• Neoplasm Metastasis

Intervention

Other:
• Malignant lymph nodes
Patients with a condition; either lymphoma on the neck or head and neck cancer with lymph node metastases on the neck.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Capital Region
Denmark	Technical University of Denmark	Lyngby	Capital Region

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Technical University of Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 minute
Secondary	Vessel distribution	Visual distribution of the nodal microvasculature	1 minute
Secondary	Microvessel density	The ratio of the vessel volume to the full volume in different regions	1 minute
Secondary	Distance between vessels	The distance between vessels in different areas in microns	1 minute
Secondary	Size of avascular areas	In mm2	1 minute
Secondary	Degree of tortuosity	Tortuosity index. The actual track path divided by the shortest linear distance from the start to the end of the track	1 minute
Secondary	Volume flow	In mm3/s	1 minute
Secondary	Flow velocity	In mm/s	1 minute