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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Tuo Li, Vice Professor
- Telefonnummer: +86-13918507887
- E-post: zoe_leeto@hotmail.com
Studieorter
-
-
Huangpu District
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Shanghai, Huangpu District, Kina, 200003
- Rekrytering
- Shanghai Changzheng Hospital
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Huvudutredare:
- Tuo Li, MD
-
Huvudutredare:
- Yongquan Shi, MD
-
Kontakt:
- Tuo Li, MD
- Telefonnummer: +86-13918507887
- E-post: zoe_leeto@hotmail.com
-
Kontakt:
- Wei-yi Zhou, MD
- Telefonnummer: +86-18689756502
- E-post: weiyizhou@smmu.edu.cn
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Underutredare:
- Jian Zhou, MD
-
Underutredare:
- Weiyi Zhou, MD
-
Underutredare:
- Jingmin Feng, MD
-
Underutredare:
- Xiaoyun Feng, MD
-
Underutredare:
- Lianqun Wu, MD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
TAO
Participants with Thyroid Associated Ophthalmopathy
|
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).
|
|
Normal
healthy individuals without thyroid-associated ophthalmopathy
|
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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic accuracy (AUC) of the AI model for TED
Tidsram: From enrollment to the end of follow-up at 18 months
|
using comprehensive clinical diagnosis (Bartley criteria) as the gold standard.
|
From enrollment to the end of follow-up at 18 months
|
|
Classification accuracy of the AI model for distinguishing active versus inactive TED
Tidsram: From enrollment to the end of follow-up at 18 months
|
From enrollment to the end of follow-up at 18 months
|
|
|
Classification accuracy of the AI model for distinguishing mild versus moderate to severe TED
Tidsram: From enrollment to the end of follow-up at 18 months
|
From enrollment to the end of follow-up at 18 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AI model.
Tidsram: From enrollment to the end of follow-up at 18 months
|
From enrollment to the end of follow-up at 18 months
|
|
Inter-observer agreement (Kappa coefficient) between the AI model and clinical experts.
Tidsram: From enrollment to the end of follow-up at 18 months
|
From enrollment to the end of follow-up at 18 months
|
|
Correlation (Pearson/Spearman correlation) between imaging features and pathological indicators .
Tidsram: From enrollment to the end of follow-up at 18 months
|
From enrollment to the end of follow-up at 18 months
|
|
Predictive performance of the AI model for treatment response, assessed by comparing baseline and follow-up ultrasound data.
Tidsram: From enrollment to the end of follow-up at 18 months
|
From enrollment to the end of follow-up at 18 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Genetiska sjukdomar, medfödda
- Autoimmuna sjukdomar
- Immunsystemets sjukdomar
- Ögonsjukdomar
- Ögonsjukdomar, ärftliga
- Exoftalmos
- Orbitala sjukdomar
- Struma
- Hypertyreos
- Sköldkörtelsjukdomar
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- Graves Oftalmopati
- Graves sjukdom
Andra studie-ID-nummer
- TED-SCOPE-MR
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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