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

Sponsor
Dong Jun Lim (Other)
Overall Status
Recruiting
CT.gov ID
NCT04879173
Collaborator
(none)
50
1
23.6
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Clinical Value of Microvascular Ultrasonography in Real-time Differential Diagnosis of Thyrotoxic Patients Between Hyperthyroidism and Thyroiditis
Actual Study Start Date :
Oct 14, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The optimal value of vascular index for differentiating the thyrotoxicosis reason [12 months]

Secondary Outcome Measures

  1. The superiority value of Microvascular flow imaging [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Initial presentation with thyrotoxicosis
Exclusion Criteria:
  • Past history of thyroidectomy

  • Factitious thyrotoxicosis

  • Unable for ultrasound

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul St. Mary hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Dong Jun Lim

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dong Jun Lim, professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT04879173
Other Study ID Numbers:
  • Project name 2
First Posted:
May 10, 2021
Last Update Posted:
May 10, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2021