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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Tuo Li, Vice Professor
- 전화번호: +86-13918507887
- 이메일: zoe_leeto@hotmail.com
연구 장소
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Huangpu District
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Shanghai, Huangpu District, 중국, 200003
- 모병
- Shanghai Changzheng Hospital
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수석 연구원:
- Tuo Li, MD
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수석 연구원:
- Yongquan Shi, MD
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연락하다:
- Tuo Li, MD
- 전화번호: +86-13918507887
- 이메일: zoe_leeto@hotmail.com
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연락하다:
- Wei-yi Zhou, MD
- 전화번호: +86-18689756502
- 이메일: weiyizhou@smmu.edu.cn
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부수사관:
- Jian Zhou, MD
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부수사관:
- Weiyi Zhou, MD
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부수사관:
- Jingmin Feng, MD
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부수사관:
- Xiaoyun Feng, MD
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부수사관:
- Lianqun Wu, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic accuracy (AUC) of the AI model for TED
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
기간 |
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Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AI model.
기간: 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.
기간: 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 .
기간: 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.
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
MRI scan，ocular ultrasound에 대한 임상 시험
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