Hyperthyroidism/ThyrotoxicosisNCT04879173
Clinical Value of Microvascular Ultrasonography in Real-time Differential Diagnosis of Thyrotoxic Patients
An observational study of Hyperthyroidism/Thyrotoxicosis, run by Dong Jun Lim at 1 site in South Korea.
Trial summary
This study aims to verify the clinical value of thyroid ultrasound with microvascular flow imaging in thyrotoxic patients for differential diagnosis between hyperthyroidism and thyroiditis. We intend to use the RS85 Ultrasound device manufactured by Samsung Medison. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperthyroidism/Thyrotoxicosis
- What is being tested?
- RS85 Ultrasound device
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Oct 2020to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with thyrotoxicosis initially presented at hospital.
Who may be able to join
- Initial presentation with thyrotoxicosis
Who cannot join
- Past history of thyroidectomy
- Factitious thyrotoxicosis
- Unable for ultrasound
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary hospital
Seoul
Dong Jun Lim, MD, PhD
About this study
Official title: The Clinical Value of Microvascular Ultrasonography in Real-time Differential Diagnosis of Thyrotoxic Patients Between Hyperthyroidism and Thyroiditis
This study aims to verify the clinical value of thyroid ultrasound with microvascular flow imaging in thyrotoxic patients for differential diagnosis between hyperthyroidism and thyroiditis. We intend to use the RS85 Ultrasound device manufactured by Samsung Medison. Graves' disease and painless thyroiditis/subacute thyroiditis are the main cause of thyrotoxicosis.
Precise discrimination between Graves' disease and painless thyroiditis/subacute thyroiditis is clinically very important in determining treatment methods, such as the prescription of antithyroid drugs. Primary endpoint was to verify the value of vascularity index, defined by Blood pixel in range of image / Total pixel in range of image .Seondary endpoint was to verify the superiority value of Microvascular flow imaging to discriminate thyrotoxicosis patients compared with Color doppler/ Power doppler ultrasound imaging and conventional ultrasound imaging.
Read the detailed description
Thyrotoxicosis refers to the appearance of various clinical symptoms or signs due to and excessive increase of thyroid hormone in the body. Graves' disease, which causes thyrotoxicosis, is one of the most common autoimmune diseases and is known to account for 0.5% of the population. Precise discrimination between Graves' disease and painless thyroiditis/subacute thyroiditis is clinically very important in determining treatment methods.
The Microvascular flow imaging technology is expected to show higher sensitivity and accuracy than conventional color Doppler images in differentiating patients between Graves' disease and painless thyroiditis/subacute thyroiditis. We enrolled thyrotoxicosis patients in their initial presentation and used RS85 Ultrasound device manufactured by Samsung Medison to discriminate Graves' disease and painless thyroiditis/subacute thyroiditis. Power / Color doppler ultrasound imaging and conventional ultrasound imaging were used. Tranverse and longitudinal plane of the dominant lobe were selected for imaging. Doppler Adler's method was used to asscess vascularization. To assess the vascularity index, which is defined by Blood pixel in range of image / Total pixel in range of image, we selected the total tranverse plane of the thyroid as range of image.
- Conditions
- Hyperthyroidism/Thyrotoxicosis
- Being tested
- RS85 Ultrasound device
- Medical subject headings
- Hyperthyroidism, Thyrotoxicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS85 Ultrasound deviceDevice
RS85 Ultrasound device manufactured by Samsung Medison
| Study group | Role | What they receive |
|---|---|---|
| Hyperthyroidism caused by Graves' disease | Not described Receives: Device: RS85 Ultrasound device | |
| Hyperthyroidism caused by painless/subacute thyroiditis | Not described Receives: Device: RS85 Ultrasound device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The optimal value of vascular index for differentiating the thyrotoxicosis reason
Measured: 12 months
Secondary outcomes (1)
The superiority value of Microvascular flow imaging
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start14 Oct 2020
- Primary completionOct 2021 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperthyroidism/ThyrotoxicosisStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Jun Lim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Jun Lim, Seoul St. Mary's Hospital
- Investigators
- Dong Jun Lim, MD, PhD, Study director, the Catholic Univerisity of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879173
- Sponsor's protocol ID
- Project name 2
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baek HS, Park JY, Jeong CH, Ha J, Kang MI, Lim DJ. Usefulness of Real-Time Quantitative Microvascular Ultrasonography for Differentiation of Graves' Disease from Destructive Thyroiditis in Thyrotoxic Patients. Endocrinol Metab (Seoul). 2022 Apr;37(2):323-332. doi: 10.3803/EnM.2022.1413. Epub 2022 Apr 13.
PubMed 35413779
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Value of Microvascular Ultrasonography in Real-time Differential Diagnosis of Thyrotoxic Patients Between Hyperthyroidism and Thyroiditis
- ClinicalTrials.gov ID
- NCT04879173
- Acronym / sponsor ID
- Project name 2
- Conditions
- Hyperthyroidism/Thyrotoxicosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dong Jun LimUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 10 May 2021 (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.
This study aims to verify the clinical value of thyroid ultrasound with microvascular flow imaging in thyrotoxic patients for differential diagnosis between hyperthyroidism and thyroiditis. We intend to use the RS85 Ultrasound device manufactured by Samsung Medison. Graves' disease and painless thyroiditis/subacute thyroiditis are the main cause of thyrotoxicosis.
Precise discrimination between Graves' disease and painless thyroiditis/subacute thyroiditis is clinically very important in determining treatment methods, such as the prescription of antithyroid drugs. Primary endpoint was to verify the value of vascularity index, defined by Blood pixel in range of image / Total pixel in range of image .Seondary endpoint was to verify the superiority value of Microvascular flow imaging to discriminate thyrotoxicosis patients compared with Color doppler/ Power doppler ultrasound imaging and conventional ultrasound imaging.
Detailed description
Thyrotoxicosis refers to the appearance of various clinical symptoms or signs due to and excessive increase of thyroid hormone in the body. Graves' disease, which causes thyrotoxicosis, is one of the most common autoimmune diseases and is known to account for 0.5% of the population. Precise discrimination between Graves' disease and painless thyroiditis/subacute thyroiditis is clinically very important in determining treatment methods.
The Microvascular flow imaging technology is expected to show higher sensitivity and accuracy than conventional color Doppler images in differentiating patients between Graves' disease and painless thyroiditis/subacute thyroiditis. We enrolled thyrotoxicosis patients in their initial presentation and used RS85 Ultrasound device manufactured by Samsung Medison to discriminate Graves' disease and painless thyroiditis/subacute thyroiditis. Power / Color doppler ultrasound imaging and conventional ultrasound imaging were used. Tranverse and longitudinal plane of the dominant lobe were selected for imaging. Doppler Adler's method was used to asscess vascularization. To assess the vascularity index, which is defined by Blood pixel in range of image / Total pixel in range of image, we selected the total tranverse plane of the thyroid as range of image.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperthyroidism caused by Graves' disease | – | Device: RS85 Ultrasound device |
| Hyperthyroidism caused by painless/subacute thyroiditis | – | Device: RS85 Ultrasound device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with thyrotoxicosis initially presented at hospital.
Key inclusion criteria (1 listed)
- Initial presentation with thyrotoxicosis
Key exclusion criteria (3 listed)
- Past history of thyroidectomy
- Factitious thyrotoxicosis
- Unable for ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RS85 Ultrasound deviceRS85 Ultrasound device manufactured by Samsung Medison | Device | Hyperthyroidism caused by Graves' disease, Hyperthyroidism caused by painless/subacute thyroiditis |
Primary outcome
The optimal value of vascular index for differentiating the thyrotoxicosis reason
Time frame: 12 months
1 secondary outcome
The superiority value of Microvascular flow imaging
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Derived from this study: PubMed 35413779Baek HS, Park JY, Jeong CH, Ha J, Kang MI, Lim DJ. Usefulness of Real-Time Quantitative Microvascular Ultrasonography for Differentiation of Graves' Disease from Destructive Thyroiditis in Thyrotoxic Patients. Endocrinol Metab (Seoul). 2022 Apr;37(2):323-332. doi: 10.3803/EnM.2022.1413. Epub 2022 Apr 13.
- Individual participant dataSharing planned: No
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Thyrotoxicosis
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. This study is not recruiting at the moment.
Dong Jun Lim, MD, PhD study director
the Catholic Univerisity of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthyroidism/Thyrotoxicosis, run by Dong Jun Lim at 1 site in South Korea.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Jun Lim, MD,PhD (82222581220, ldj6026@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The optimal value of vascular index for differentiating the thyrotoxicosis reason (time frame: 12 months). 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 NCT04879173, which also lists 1 linked publication.
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 10 May 2021.