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

NCT06585592 | Completed

• 1 other identifier: TAO3M-1
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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. 1.Found characteristic changes from baseline to the end of treatment.
2. 2.Identify characteristic changes associated with treatment response.
3. 3.Construct a multimodal and multiparameter prediction model by characteristic changes.

Conditions

Thyroid-Associated Ophthalmopathy

Outcome Measures

Primary Outcomes (4)

• Percentage of participants with overall response

  Overall response

  1 week after the end of treatment

• Percentage of participants with overall response

  Overall response

  24 weeks after the end of treatment

• Percentage of participants with overall response

  Overall response

  52 weeks after the end of treatment

• Percentage of participants with overall response

  Overall response

  104 weeks after the end of treatment

Secondary Outcomes (6)

• Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) during the treament

  during the treament

• Change of Serum TRAb from baseline

  52 weeks after the end of treatment

• Change of Serum T3,T4 level from baseline

  52 weeks after the end of treatment

• Change of Serum lipid parameter

  52 weeks after the end of treatment

• Change of Serum TSH level from baseline

  52 weeks after the end of treatment

Other Outcomes (3)

• Change of extraocular muscle volume and orbital fat volume by MR

  52 weeks after the end of treatment

• change of extraocular muscle volume and orbital fat volume by MRI

  4 weeks after the end of treatment

• change of extraocular muscle volume and orbital fat volume by MRI

  24 weeks after the end of treatment

Study Arms (1)

TAO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate to severe active TAO patients who received complete medical treatment and completed assessment .

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Related Publications (3)

• 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.

  PMID: 34252869 BACKGROUND

• 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.

  PMID: 36780178 BACKGROUND

• 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.

  PMID: 35092642 BACKGROUND

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 5, 2024
• Study Start: January 1, 2017
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share