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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT05754814

Collaborator

Technical University of Denmark (Other), University of Copenhagen (Other)

100

Enrollment

Locations

22.1

Anticipated Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Lymphoma Lymph Node Metastasis	Other: Malignant lymph nodes

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jun 28, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Controls Healthy participants
Cases Patients with malignant lymph nodes on the neck	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.

Arm

Intervention/Treatment

Controls

Healthy participants

Cases

Patients with malignant lymph nodes on the neck

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.

Outcome Measures

Primary Outcome Measures

Super-resolution ultrasound image of normal and malignant human lymph nodes [1 minute]
With super-resolution ultrasound imaging, the investigators will visualize the microvasculature in the lymph nodes.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.