Thyroid Nodular DiseaseNCT07041307
Microvascular Profiling of Nodules in the Thyroid Gland
An observational study of Thyroid Nodular Disease, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Nodular Disease
- How many people
- 50 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Aug 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Nathalie Sarup Panduro, MD, +4529273193, nathalie04@gmail.com
Michael Bachmann Nielsen, Professor PhD dr.med., +4535458233, mbn@dadlnet.dk
- Recruiting
Technical University of Denmark
Lyngby, 2800
Nathalie Sarup Panduro, MD, +4529273193, nathalie04@gmail.com
Jørgen Arendt Jensen, Prof. PhD, +4545253924, jaje@dtu.dk
About this study
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.
Read the 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.
- Conditions
- Thyroid Nodular Disease
- Keywords
- thyroid nodules, super-resolution ultrasound
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (1)
Quantification of the Microvasculature
Quantification of the thyroid microvasculature and the microvasculature in thyroid nodules. This includes vessel density, vessel diameters, blood flow velocity and vessel distribution.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start15 Aug 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Thyroid Nodular DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Technical University of Denmark
- Responsible party
- Principal investigator, Nathalie Sarup Panduro, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Michael Bachmann Nielsen, Professor PhD dr.med., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041307
- Sponsor's protocol ID
- SURE-THYROID
- Status last verified
- Nov 2025
- First submitted
- 19 Jun 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38857146Arendt 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.
PubMed 38857145Erdogan 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.
PubMed 17381355Pedersen 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.
PubMed 10779140Carmeliet P, Jain RK. Angiogenesis in cancer and other diseases. Nature. 2000 Sep 14;407(6801):249-57. doi: 10.1038/35025220.
PubMed 11001068Arjan 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.
PubMed 9888858Russ 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.
PubMed 29167761Knudsen 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.
PubMed 11012573
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Profiling of Nodules in the Thyroid Gland
- ClinicalTrials.gov ID
- NCT07041307
- Acronym / sponsor ID
- SURE-THYROID
- Conditions
- Thyroid Nodular Disease
- Keywords
- thyroid nodules, super-resolution ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen, Technical University of Denmark
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Quantification of the Microvasculature
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Background: PubMed 38857146Naji 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.
- Background: PubMed 38857145Arendt 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.
- Background: PubMed 17381355Erdogan 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.
- Background: PubMed 10779140Pedersen 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.
- Background: PubMed 11001068Carmeliet P, Jain RK. Angiogenesis in cancer and other diseases. Nature. 2000 Sep 14;407(6801):249-57. doi: 10.1038/35025220.
- Background: PubMed 9888858Arjan 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.
- Background: PubMed 29167761Russ 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.
- Background: PubMed 11012573Knudsen 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Bachmann Nielsen, Professor PhD dr.med. principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodular Disease, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Sarup Panduro, MD (+4529273193, nathalie04@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of the Microvasculature in the Thyroid Gland and Thyroid Nodules (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07041307, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.