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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Tuo Li, Vice Professor
- Telefonnummer: +86-13918507887
- E-post: zoe_leeto@hotmail.com
Studiesteder
-
-
Huangpu District
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Shanghai, Huangpu District, Kina, 200003
- Rekruttering
- Shanghai Changzheng Hospital
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Hovedetterforsker:
- Tuo Li, MD
-
Hovedetterforsker:
- Yongquan Shi, MD
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Ta kontakt med:
- Tuo Li, MD
- Telefonnummer: +86-13918507887
- E-post: zoe_leeto@hotmail.com
-
Ta kontakt med:
- Wei-yi Zhou, MD
- Telefonnummer: +86-18689756502
- E-post: weiyizhou@smmu.edu.cn
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Underetterforsker:
- Jian Zhou, MD
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Underetterforsker:
- Weiyi Zhou, MD
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Underetterforsker:
- Jingmin Feng, MD
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Underetterforsker:
- Xiaoyun Feng, MD
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Underetterforsker:
- Lianqun Wu, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic accuracy (AUC) of the AI model for TED
Tidsramme: 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
Tidsramme: 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
Tidsramme: From enrollment to the end of follow-up at 18 months
|
From enrollment to the end of follow-up at 18 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AI model.
Tidsramme: 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.
Tidsramme: 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 .
Tidsramme: 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.
Tidsramme: From enrollment to the end of follow-up at 18 months
|
From enrollment to the end of follow-up at 18 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
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- Genetiske sykdommer, medfødte
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- Orbitale sykdommer
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- Skjoldbrusk sykdommer
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Graves Oftalmopati
- Graves 'sykdom
Andre studie-ID-numre
- TED-SCOPE-MR
Plan for individuelle deltakerdata (IPD)
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