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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Tuo Li, Vice Professor
- 電話番号：+86-13918507887
- メール：zoe_leeto@hotmail.com
研究場所
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Huangpu District
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Shanghai、Huangpu District、中国、200003
- 募集
- Shanghai Changzheng Hospital
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主任研究者：
- Tuo Li, MD
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主任研究者：
- Yongquan Shi, MD
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コンタクト：
- Tuo Li, MD
- 電話番号：+86-13918507887
- メール：zoe_leeto@hotmail.com
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コンタクト：
- Wei-yi Zhou, MD
- 電話番号：+86-18689756502
- メール：weiyizhou@smmu.edu.cn
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副調査官：
- Jian Zhou, MD
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副調査官：
- Weiyi Zhou, MD
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副調査官：
- Jingmin Feng, MD
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副調査官：
- Xiaoyun Feng, MD
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副調査官：
- Lianqun Wu, MD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Diagnostic accuracy (AUC) of the AI model for TED
時間枠：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
時間枠：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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|
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Classification accuracy of the AI model for distinguishing mild versus moderate to severe TED
時間枠：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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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AI model.
時間枠：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.
時間枠：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 .
時間枠：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.
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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