Microvascular Profiling of Nodules in the Thyroid Gland

NCT07041307 | Recruiting

• 1 other identifier: SURE-THYROID
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to examine tiny blood vessels in different thyroid nodules using advanced ultrasound. In the long term, we hope this can help doctors better tell the difference between types of nodules and more accurately decide who may need surgery.

Conditions

Thyroid Nodular Disease

Keywords

thyroid nodules; super-resolution ultrasound

Outcome Measures

Primary Outcomes (1)

• Visualization of the Microvasculature in the Thyroid Gland and Thyroid Nodules

  With super-resolution ultrasound imaging using the erythrocytes, the investigators will visualize the microvasculature in normal thyroid tissue and different types of thyroid nodules.

  30 minutes

Secondary Outcomes (1)

• Quantification of the Microvasculature

  30 minutes

Study Arms (5)

Healthy Participants

Normal Thyroid Gland

Thyroid Cancer

Malignant Thyroid Nodule

Hyperfunctioning Nodules

Benign, Hyperfunctioning Thyroid Nodules

Isofunctioning Nodules

Benign, Isofunctioning Thyroid Nodules

Hypofunctioning Nodules

Benign, Hypofunctioning Thyroid Nodules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers will be recruited through posters displayed at public institutions such as universities, libraries, and similar locations, as well as via the website https://forskningnu.dk/. Patients will be recruited from the Department of Clinical Physiology and Nuclear Medicine, and the Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, both located at Rigshospitalet, Denmark.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University of Copenhagen: collaborator
• Technical University of Denmark: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Technical University of Denmark

Lyngby, 2800, Denmark

RECRUITING

Related Publications (8)

• Naji MA, Taghavi I, Schou M, Praesius SK, Hansen LN, Panduro NS, Andersen SB, Sogaard SB, Gundlach C, Kjer HM, Tomov BG, Thomsen EV, Nielsen MB, Larsen NB, Dahl AB, Sorensen CM, Jensen JA. Super-Resolution Ultrasound Imaging Using the Erythrocytes-Part II: Velocity Images. IEEE Trans Ultrason Ferroelectr Freq Control. 2024 Aug;71(8):945-959. doi: 10.1109/TUFFC.2024.3411795. Epub 2024 Aug 19.

  PMID: 38857146 BACKGROUND

• Arendt Jensen J, Amin Naji M, Kazmarek PraeSius S, Taghavi I, Schou M, Naur Hansen L, Bech Andersen S, Byrholdt Sogaard S, Sarup Panduro N, Mehlin Sorensen C, Bachmann Nielsen M, Gundlach C, Martin Kjer H, Bjorholm Dahl A, Gueorguiev Tomov B, Lind Ommen M, Bent Larsen N, Vilain Thomsen E. Super-Resolution Ultrasound Imaging Using the Erythrocytes-Part I: Density Images. IEEE Trans Ultrason Ferroelectr Freq Control. 2024 Aug;71(8):925-944. doi: 10.1109/TUFFC.2024.3411711. Epub 2024 Aug 19.

  PMID: 38857145 BACKGROUND

• Erdogan MF, Anil C, Cesur M, Baskal N, Erdogan G. Color flow Doppler sonography for the etiologic diagnosis of hyperthyroidism. Thyroid. 2007 Mar;17(3):223-8. doi: 10.1089/thy.2006.0104.

  PMID: 17381355 BACKGROUND

• Pedersen OM, Aardal NP, Larssen TB, Varhaug JE, Myking O, Vik-Mo H. The value of ultrasonography in predicting autoimmune thyroid disease. Thyroid. 2000 Mar;10(3):251-9. doi: 10.1089/thy.2000.10.251.

  PMID: 10779140 BACKGROUND

• Carmeliet P, Jain RK. Angiogenesis in cancer and other diseases. Nature. 2000 Sep 14;407(6801):249-57. doi: 10.1038/35025220.

  PMID: 11001068 BACKGROUND

• Arjan JA, Visser M, Zeyl CW, Gerrish PJ, Blanchard JL, Lenski RE. Diminishing returns from mutation supply rate in asexual populations. Science. 1999 Jan 15;283(5400):404-6. doi: 10.1126/science.283.5400.404.

  PMID: 9888858 BACKGROUND

• Russ G, Bonnema SJ, Erdogan MF, Durante C, Ngu R, Leenhardt L. European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: The EU-TIRADS. Eur Thyroid J. 2017 Sep;6(5):225-237. doi: 10.1159/000478927. Epub 2017 Aug 8.

  PMID: 29167761 BACKGROUND

• Knudsen N, Bulow I, Jorgensen T, Laurberg P, Ovesen L, Perrild H. Goitre prevalence and thyroid abnormalities at ultrasonography: a comparative epidemiological study in two regions with slightly different iodine status. Clin Endocrinol (Oxf). 2000 Oct;53(4):479-85. doi: 10.1046/j.1365-2265.2000.01121.x.

  PMID: 11012573 BACKGROUND

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Michael Bachmann Nielsen, Professor PhD dr.med.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Sarup Panduro, MD

CONTACT

+4529273193; nathalie04@gmail.com

Michael Bachmann Nielsen, Professor PhD dr.med.

CONTACT

+4535458233; mbn@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)