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

Hyperthyroidism/Thyrotoxicosis Clinical Trial

Official title:

The Clinical Value of Microvascular Ultrasonography in Real-time Differential Diagnosis of Thyrotoxic Patients Between Hyperthyroidism and Thyroiditis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879173
• Other study ID #: Project name 2
• Status: Recruiting
• Start date: October 14, 2020
• Est. completion date: October 2022

Study information

• Verified date: May 2021
• Source: Seoul St. Mary's Hospital
• Contact: Dong Jun Lim, MD,PhD
• Phone: 82222581220
• Email: ldj6026[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Initial presentation with thyrotoxicosis

Exclusion Criteria:

• Past history of thyroidectomy

• Factitious thyrotoxicosis

• Unable for ultrasound

Related Conditions & MeSH terms

• Hyperthyroidism
• Hyperthyroidism/Thyrotoxicosis
• Thyrotoxicosis

Intervention

Device:
• RS85 Ultrasound device
RS85 Ultrasound device manufactured by Samsung Medison

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong Jun Lim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The optimal value of vascular index for differentiating the thyrotoxicosis reason		12 months
Secondary	The superiority value of Microvascular flow imaging		12 months