Clinical Value of Microvascular Ultrasonography in Real-time Differential Diagnosis of Thyrotoxic Patients

NCT ID: NCT04879173

Last Updated: 2021-05-10

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-14

Study Completion Date

2022-10-31

Brief Summary

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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

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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

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Hyperthyroidism/Thyrotoxicosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Hyperthyroidism caused by Graves' disease

RS85 Ultrasound device

Intervention Type DEVICE

RS85 Ultrasound device manufactured by Samsung Medison

Hyperthyroidism caused by painless/subacute thyroiditis

RS85 Ultrasound device

Intervention Type DEVICE

RS85 Ultrasound device manufactured by Samsung Medison

Interventions

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RS85 Ultrasound device

RS85 Ultrasound device manufactured by Samsung Medison

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Initial presentation with thyrotoxicosis

Exclusion Criteria

* Past history of thyroidectomy
* Factitious thyrotoxicosis
* Unable for ultrasound
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong Jun Lim

OTHER

Sponsor Role lead

Responsible Party

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Dong Jun Lim

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dong Jun Lim, MD, PhD

Role: STUDY_DIRECTOR

the Catholic Univerisity of Korea

Locations

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Seoul St. Mary hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Jun Lim, MD,PhD

Role: CONTACT

82222581220

Facility Contacts

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Dong Jun Lim, MD, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35413779 (View on PubMed)

Other Identifiers

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Project name 2

Identifier Type: -

Identifier Source: org_study_id

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