Screening, Classification, and Outcome Prediction Ensemble Using Orbital MRI for Thyroid Eye Disease: The TED SCOPE National Multicenter Registry Study (TED-SCOPE-MR)
Construction and Optimization of a Multimodal Orbital MRI-AI Model and Its Application in Thyroid Eye Disease: A National Multicenter Registry Study
The goal of this observational study is to prospectively validate the efficacy of an AI multimodal model constructed based on multi - sequence orbital MRI in the diagnosis, activity and severity assessment, and prognosis prediction of thyroid - associated ophthalmopathy (TAO) in real - world clinical scenarios. The main questions it aims to answer are:
Can AI models accurately assess the presence, activity, and severity of Thyroid-Associated Orbitopathy (TAO)? Can AI models predict the prognosis of TAO? Researchers will compare the diagnostic accuracy of the AI model for TAO patients and healthy subjects to evaluate its diagnostic performance.
Participants will undergo a standardized, study - specific multimodal orbital MRI scan (sequences include T1WI, T2WI, STIR, and research sequences such as Magic, IDEAL - IQ, DWI, ASL, CEST). And will systematically acquire ocular ultrasound images from TED patients (active and inactive stages), non-TED ophthalmic disease controls, and healthy volunteers. AI-driven deep learning techniques (convolutional neural networks) will be applied to achieve automatic segmentation of key structures (extraocular muscles, optic nerve, lacrimal gland, and retrobulbar soft tissue). High-throughput radiomic features encompassing morphological parameters and gray-level texture patterns will be extracted. Machine learning algorithms will then be employed to construct objective prediction models for TED screening and activity staging, with MRI findings and CAS scores serving as the reference standards for external validation.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Tuo Li, Vice Professor
- 电话号码：+86-13918507887
- 邮箱：zoe_leeto@hotmail.com
学习地点
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Huangpu District
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Shanghai、Huangpu District、中国、200003
- 招聘中
- Shanghai Changzheng Hospital
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首席研究员：
- Tuo Li, MD
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首席研究员：
- Yongquan Shi, MD
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接触：
- Tuo Li, MD
- 电话号码：+86-13918507887
- 邮箱：zoe_leeto@hotmail.com
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接触：
- Wei-yi Zhou, MD
- 电话号码：+86-18689756502
- 邮箱：weiyizhou@smmu.edu.cn
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副研究员：
- Jian Zhou, MD
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副研究员：
- Weiyi Zhou, MD
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副研究员：
- Jingmin Feng, MD
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副研究员：
- Xiaoyun Feng, MD
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副研究员：
- Lianqun Wu, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
TAO patient group
Age between 18 and 75 years old, regardless of gender.
Patients with thyroid eye disease who meet the disease staging and grading criteria specified in diagnostic guidelines such as those of Bartley, CAS, and EUGOGO.
The patient has planned or received thyroid-related treatment, and the condition is relatively stable.
- Voluntarily participate in this study and sign the informed consent form.
Control group:
① Healthy volunteers matched with the TAO group in terms of age and gender.
② Voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria:
TAO patient group:
Pregnant or lactating women.
Patients with other orbital lesions.
③ Having contraindications for MRI examination (such as non - compatible metal implants in the body, claustrophobia, etc.).
④ The patient has previously received orbital radiotherapy or orbital surgery (except for patients who need to collect tissue specimens).
⑤ Comorbid with other severe systemic diseases (such as uncontrolled heart failure, liver and kidney failure) or mental illnesses, and unable to cooperate to complete the study.
⑥ Participated in other clinical trials that may interfere with the results of this study within 3 months.
Control group:
Same as the exclusion criteria 1 - 6 for the TAO patient group
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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TAO
Participants with Thyroid Associated Ophthalmopathy
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Participants will undergo a standardized, study - specific multimodal orbital MRI scan (sequences include T1WI, T2WI, STIR, and research sequences such as Magic, IDEAL - IQ, DWI, ASL, CEST).
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Normal
healthy individuals without thyroid-associated ophthalmopathy
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Participants will undergo a standardized, study - specific multimodal orbital MRI scan (sequences include T1WI, T2WI, STIR, and research sequences such as Magic, IDEAL - IQ, DWI, ASL, CEST).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnostic accuracy (AUC) of the AI model for TED
大体时间：From enrollment to the end of follow-up at 18 months
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using comprehensive clinical diagnosis (Bartley criteria) as the gold standard.
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From enrollment to the end of follow-up at 18 months
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Classification accuracy of the AI model for distinguishing active versus inactive TED
大体时间：From enrollment to the end of follow-up at 18 months
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From enrollment to the end of follow-up at 18 months
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Classification accuracy of the AI model for distinguishing mild versus moderate to severe TED
大体时间：From enrollment to the end of follow-up at 18 months
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From enrollment to the end of follow-up at 18 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AI model.
大体时间：From enrollment to the end of follow-up at 18 months
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From enrollment to the end of follow-up at 18 months
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Inter-observer agreement (Kappa coefficient) between the AI model and clinical experts.
大体时间：From enrollment to the end of follow-up at 18 months
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From enrollment to the end of follow-up at 18 months
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Correlation (Pearson/Spearman correlation) between imaging features and pathological indicators .
大体时间：From enrollment to the end of follow-up at 18 months
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From enrollment to the end of follow-up at 18 months
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Predictive performance of the AI model for treatment response, assessed by comparing baseline and follow-up ultrasound data.
大体时间：From enrollment to the end of follow-up at 18 months
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From enrollment to the end of follow-up at 18 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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