Visualizing small blood vessels in lymph nodes using advanced ultrasound
SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph Nodes
This study is testing a new ultrasound technique to see if it can help tell the difference between healthy and cancerous lymph nodes in the neck.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | Imatinib |
| Locations | 2 sites (Copenhagen, Capital Region and 1 other locations) |
| Trial ID | NCT05754814 on ClinicalTrials.gov |
What this trial studies
This observational study aims to utilize a novel ultrasound technique called super-resolution ultrasound imaging of erythrocytes (SURE) to visualize small blood vessels in normal and cancerous lymph nodes in the neck. The study will compare lymph nodes from healthy participants with those from individuals diagnosed with head and neck cancer or lymphoma. Participants will undergo ultrasound scans using both standard and SURE techniques to assess the feasibility and clinical relevance of this advanced imaging method. The goal is to determine if SURE can effectively distinguish between healthy and malignant lymph nodes based on vascular characteristics.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with either untreated head and neck cancer or lymphoma, as well as healthy individuals with normal lymph nodes.
Not a fit: Patients with advanced cancer requiring immediate treatment or those unable to lie still for the ultrasound may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could lead to earlier diagnoses and improved treatment evaluations for patients with head and neck cancer and lymphoma.
How similar studies have performed: While the SURE technique is novel, previous studies using advanced imaging methods for vascular assessment in cancer have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Copenhagen, Capital Region and 1 other locations
- Rigshospitalet — Copenhagen, Capital Region, Denmark (Recruiting)
- Technical University of Denmark — Lyngby, Capital Region, Denmark (Recruiting)
Study contacts
- Principal investigator: Nathalie Sarup Panduro, MD — The Department of Diagnostic Radiology, Rigshospitalet
- Study coordinator: Nathalie Sarup Panduro, MD
- Email: nathalie04@gmail.com
- Phone: +4529273193
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.