Clinical trial NCT06585592: Establishment of Multimodal-multiparametric Progressive Prediction Models for Thyroid Associated Ophthalmopathy
Official title: Establishment of Multimodal-multiparametric Progressive Prediction Models for Thyroid Associated Ophthalmopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid-Associated Ophthalmopathy
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate to severe active TAO patients who received complete medical treatment and completed assessment .

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.


Eligibility criteria: Inclusion Criteria:

* According to the Bartley criteria，diagnosed TAO at our hospital 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 \&gt;1 g of methylprednisolone for the treatment of TAO.
* Any major illness/condition or evidence of an unstable clinical condition that, in the investigator\&#39;s 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 participant\&#39;s participation in the study
* Pregnant or lactating
* Any other condition that,would impair the ability of the participant to undergo orbital MRI

Primary outcomes:
measure: Percentage of participants with overall response
timeFrame: 1 week after the end of treatment
measure: Percentage of participants with overall response
timeFrame: 24 weeks after the end of treatment
measure: Percentage of participants with overall response
timeFrame: 52 weeks after the end of treatment
measure: Percentage of participants with overall response
timeFrame: 104 weeks after the end of treatment
Secondary outcomes:
measure: Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
timeFrame: 1 week after the end of treatment
measure: Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
timeFrame: 52 weeks after the end of treatment
measure: Change of Serum TRAb
timeFrame: 52 weeks after the end of treatment
measure: Change of Serum thyroid function
timeFrame: 52 weeks after the end of treatment
measure: Change of Serum lipid parameter
timeFrame: 52 weeks after the end of treatment
Other outcomes:
measure: MRI
timeFrame: baseline
measure: MRI
timeFrame: 52 weeks after the end of treatment
measure: MRI
timeFrame: 1 week after the end of treatment
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.