Microvascular Profiling of Nodules in the Thyroid Gland

NCT ID: NCT07041307

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-15

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Thyroid Nodular Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy Participants

Normal Thyroid Gland

No interventions assigned to this group

Thyroid Cancer

Malignant Thyroid Nodule

No interventions assigned to this group

Hyperfunctioning Nodules

Benign, Hyperfunctioning Thyroid Nodules

No interventions assigned to this group

Isofunctioning Nodules

Benign, Isofunctioning Thyroid Nodules

No interventions assigned to this group

Hypofunctioning Nodules

Benign, Hypofunctioning Thyroid Nodules

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Technical University of Denmark

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Nathalie Sarup Panduro

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Bachmann Nielsen, Professor PhD dr.med.

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Technical University of Denmark

Lyngby, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Nathalie Sarup Panduro, MD

Role: CONTACT

+4529273193

Michael Bachmann Nielsen, Professor PhD dr.med.

Role: CONTACT

+4535458233

Facility Contacts

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Nathalie Sarup Panduro, MD

Role: primary

+4529273193

Michael Bachmann Nielsen, Professor PhD dr.med.

Role: backup

+4535458233

Nathalie Sarup Panduro, MD

Role: primary

+4529273193

Jørgen Arendt Jensen, Prof. PhD

Role: backup

+4545253924

References

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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.

Reference Type BACKGROUND
PMID: 38857146 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38857145 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17381355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10779140 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11001068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9888858 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29167761 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11012573 (View on PubMed)

Related Links

Other Identifiers

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SURE-THYROID

Identifier Type: -

Identifier Source: org_study_id

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