Microvascular Profiling of Nodules in the Thyroid Gland

November 21, 2025 updated by: Nathalie Sarup Panduro, Rigshospitalet, Denmark
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Michael Bachmann Nielsen, Professor PhD dr.med.
  • Phone Number: +4535458233
  • Email: mbn@dadlnet.dk

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
        • Contact:
          • Michael Bachmann Nielsen, Professor PhD dr.med.
          • Phone Number: +4535458233
          • Email: mbn@dadlnet.dk
        • Sub-Investigator:
          • Nathalie Sarup Panduro, MD
      • Lyngby, Denmark, 2800
        • Recruiting
        • Technical University of Denmark
        • Contact:
        • Contact:
          • Jørgen Arendt Jensen, Prof. PhD
          • Phone Number: +4545253924
          • Email: jaje@dtu.dk
        • Sub-Investigator:
          • Nathalie Sarup Panduro, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

University of Copenhagen
Technical University of Denmark

Investigators

  • Principal Investigator: Michael Bachmann Nielsen, Professor PhD dr.med., Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 19, 2025

First Submitted That Met QC Criteria

June 19, 2025

First Posted (Actual)

June 27, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SURE-THYROID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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