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
1 other identifier
observational
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2020
CompletedFirst Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMay 10, 2021
May 1, 2021
12 months
May 4, 2021
May 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The optimal value of vascular index for differentiating the thyrotoxicosis reason
12 months
Secondary Outcomes (1)
The superiority value of Microvascular flow imaging
12 months
Study Arms (2)
Hyperthyroidism caused by Graves' disease
Hyperthyroidism caused by painless/subacute thyroiditis
Interventions
RS85 Ultrasound device manufactured by Samsung Medison
Eligibility Criteria
Patient with thyrotoxicosis initially presented at hospital.
You may qualify if:
- Initial presentation with thyrotoxicosis
You may not qualify if:
- Past history of thyroidectomy
- Factitious thyrotoxicosis
- Unable for ultrasound
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dong Jun Limlead
Study Sites (1)
Seoul St. Mary hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 35413779DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dong Jun Lim, MD, PhD
the Catholic Univerisity of Korea
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 10, 2021
Study Start
October 14, 2020
Primary Completion
October 1, 2021
Study Completion
October 1, 2022
Last Updated
May 10, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share