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

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperthyroidism/Thyrotoxicosis
• Intervention / Treatment: Device: RS85 Ultrasound device

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Dong Jun Lim, MD,PhD; Phone Number: 82222581220; Email: ldj6026@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul St. Mary Hospital
    • Contact: Dong Jun Lim, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with thyrotoxicosis initially presented at hospital.

Description

Inclusion Criteria:

• Initial presentation with thyrotoxicosis

Exclusion Criteria:

• Past history of thyroidectomy
• Factitious thyrotoxicosis
• Unable for ultrasound

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hyperthyroidism caused by Graves' disease	Device: RS85 Ultrasound device; RS85 Ultrasound device manufactured by Samsung Medison
Hyperthyroidism caused by painless/subacute thyroiditis	Device: RS85 Ultrasound device; RS85 Ultrasound device manufactured by Samsung Medison

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The optimal value of vascular index for differentiating the thyrotoxicosis reason	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The superiority value of Microvascular flow imaging	12 months

Collaborators and Investigators

• Sponsor: Dong Jun Lim
• Investigators: Study Director: Dong Jun Lim, MD, PhD, the Catholic Univerisity of Korea

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hyperthyroidism; Thyrotoxicosis
• Other Study ID Numbers: Project name 2

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