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Recruiting NCT07041307

Microvascular Profiling of Nodules in the Thyroid Gland

— Observational Thyroid Nodular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Thyroid Nodular Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

In this study, the investigators use an advanced ultrasound technique called Super-Resolution Ultrasound of Erythrocytes (SURE) to map the microvasculature in the thyroid gland and thyroid nodules. This method provides much higher resolution than conventional ultrasound, allowing us to visualize and measure even the smallest blood vessels.

The investigators aim to explore whether this technique can help differentiate between various types of thyroid nodules - including benign and malignant - and possibly between hyper-, iso-, and hypofunctioning nodules, based on their microvascular characteristics.

Primary outcome measures

  • Visualization of the Microvasculature in the Thyroid Gland and Thyroid Nodules [Time frame: 30 minutes]
Secondary outcome measures (1)
  • Quantification of the Microvasculature [Time frame: 30 minutes]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Denmark · 2 centers
  • Rigshospitalet — Copenhagen
  • Technical University of Denmark — Lyngby

Publications

  • 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
  • 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 Ferroel PMID 38857145
  • 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
  • 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
  • Carmeliet P, Jain RK. Angiogenesis in cancer and other diseases. Nature. 2000 Sep 14;407(6801):249-57. doi: 10.1038/35025220. PMID 11001068
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07041307 · SURE-THYROID

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗