Establishment of Multimodal-multiparametric Progressive Prediction Models for Thyroid Associated Ophthalmopathy

NCT ID: NCT06585592

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2024-03-31

Brief Summary

Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.

The aim of this clinical study is to:

1. Found characteristic changes from baseline to the end of treatment.

2. Identify characteristic changes associated with treatment response.

3. Construct a multimodal and multiparameter prediction model by characteristic changes.

Conditions

Thyroid-Associated Ophthalmopathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

TAO

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• According to the Bartley criteria，diagnosed TAO from 2017/1/1 to 2024/3/31
• Moderate to severe patients defined by EUGOGO
• CAS ≥4 (on the 7-item scale) for the study eye
• Completed orbital MRI at our hospital
• Received complete medical treatment and completed assessment at our hospital

Exclusion Criteria

• Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision
• History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to < 1 g of methylprednisolone for the treatment of TAO.
• Any major illness/condition or evidence of an unstable clinical condition that, in the investigators judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study
• Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participants participation in the study
• Pregnant or lactating
• Any other condition that,would impair the ability of the participant to undergo orbital MRI

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tuo Li, MD

Deputy Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Zhai L, Luo B, Wu H, Wang Q, Yuan G, Liu P, Ma Y, Zhao Y, Zhang J. Prediction of treatment response to intravenous glucocorticoid in patients with thyroid-associated ophthalmopathy using T2 mapping and T2 IDEAL. Eur J Radiol. 2021 Sep;142:109839. doi: 10.1016/j.ejrad.2021.109839. Epub 2021 Jul 3.

Reference Type: BACKGROUND

PMID: 34252869 (View on PubMed)

Li Z, Luo Y, Feng X, Zhang Q, Zhong Q, Weng C, Chen Z, Shen J. Application of Multiparameter Quantitative Magnetic Resonance Imaging in the Evaluation of Graves' Ophthalmopathy. J Magn Reson Imaging. 2023 Oct;58(4):1279-1289. doi: 10.1002/jmri.28642. Epub 2023 Feb 13.

Reference Type: BACKGROUND

PMID: 36780178 (View on PubMed)

Hu H, Chen L, Zhang JL, Chen W, Chen HH, Liu H, Shi HB, Wu FY, Xu XQ. T2 -Weighted MR Imaging-Derived Radiomics for Pretreatment Determination of Therapeutic Response to Glucocorticoid in Patients With Thyroid-Associated Ophthalmopathy: Comparison With Semiquantitative Evaluation. J Magn Reson Imaging. 2022 Sep;56(3):862-872. doi: 10.1002/jmri.28088. Epub 2022 Jan 29.

Reference Type: BACKGROUND

PMID: 35092642 (View on PubMed)

Other Identifiers

TAO3M-1

Identifier Type: -

Identifier Source: org_study_id