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NCT Number: NCT07041307

Microvascular Profiling of Nodules in the Thyroid Gland

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Visualization of the Microvasculature in the Thyroid Gland and Thyroid Nodules

    Time frame: 30 minutes

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

Secondary outcomes

  1. Quantification of the Microvasculature

    Time frame: 30 minutes

    Quantification of the thyroid microvasculature and the microvasculature in thyroid nodules. This includes vessel density, vessel diameters, blood flow velocity and vessel distribution.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Bachmann Nielsen, Professor PhD dr.med.

CONTACT

[email protected]

+4535458233

Nathalie Sarup Panduro, MD

CONTACT

[email protected]

+4529273193

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Technical University of Denmark
  • University of Copenhagen

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 27, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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