Mapping tiny blood vessels inside thyroid nodules.
Microvascular Profiling of Nodules in the Thyroid Gland
Rigshospitalet, Denmark · NCT07041307
This project tries a super-resolution ultrasound scan to see if mapping tiny blood vessels can help doctors tell different kinds of thyroid nodules apart in adults with nodules or referred for surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 2 sites (Copenhagen and 1 other locations) |
| Trial ID | NCT07041307 on ClinicalTrials.gov |
What this trial studies
Investigators will use Super-Resolution Ultrasound of Erythrocytes (SURE) to visualize and map microvascular networks in the thyroid gland and individual nodules at much higher resolution than conventional ultrasound. The observational imaging program will include adults with hypo-, iso-, or hyperfunctioning nodules, patients referred for thyroid surgery due to suspected malignancy, and healthy volunteers for comparison. Images will be analyzed for vessel size, density, and flow patterns to identify microvascular signatures that might differ between benign and malignant nodules and among functional classes. No experimental treatments are given; imaging findings will be compared to clinical follow-up and surgical pathology when available.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with hypo-, iso-, or hyperfunctioning thyroid nodules or patients referred for thyroid surgery due to suspected malignant nodules (Bethesda III-VI), as well as healthy volunteers without thyroid disease.
Not a fit: Patients who cannot undergo ultrasound, are pregnant, or already have a clear diagnosis and treatment plan are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, this technique could help doctors more accurately distinguish benign from malignant nodules and reduce unnecessary surgeries.
How similar studies have performed: Early pilot studies and preclinical work on super-resolution ultrasound show promise for visualizing tiny vessels, but clinical validation for distinguishing thyroid nodule types remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 years * Written and verbal informed consent to participate in the study * Patients with hypo-, iso-, or hyperfunctioning thyroid nodules * Patients referred for thyroid surgery due to suspected malignant nodule (including Bethesda classification groups III, IV, V, and VI) * Healthy volunteers - generally good health with no chronic illnesses Exclusion Criteria: * Pregnancy * Inability to undergo the examination due to physical or mental limitations * Desire to opt out of receiving information about new, significant health findings revealed during the study * Healthy Participants: * Thyroid disease, including nodules, as well as current or past conditions affecting the thyroid * Medication that affects thyroid function
Where this trial is running
Copenhagen and 1 other locations
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- Technical University of Denmark — Lyngby, Denmark (RECRUITING)
Study contacts
- Principal investigator: Michael Bachmann Nielsen, Professor PhD dr.med. — Rigshospitalet, Denmark
- 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.
Conditions: Thyroid Nodular Disease, thyroid nodules, super-resolution ultrasound