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Screening, Classification, and Outcome Prediction Ensemble Using Orbital MRI for Thyroid Eye Disease: The TED SCOPE National Multicenter Registry Study (TED-SCOPE-MR)

20. juli 2026 opdateret af: Tuo Li, MD, Shanghai Changzheng Hospital

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Huangpu District
      • Shanghai, Huangpu District, Kina, 200003
        • Rekruttering
        • Shanghai Changzheng Hospital
        • Ledende efterforsker:
          • Tuo Li, MD
        • Ledende efterforsker:
          • Yongquan Shi, MD
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Jian Zhou, MD
        • Underforsker:
          • Weiyi Zhou, MD
        • Underforsker:
          • Jingmin Feng, MD
        • Underforsker:
          • Xiaoyun Feng, MD
        • Underforsker:
          • Lianqun Wu, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Before initiating the corresponding procedures for the study, all subjects must personally sign the informed consent form approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB) and indicate the date.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
TAO
Participants with Thyroid Associated Ophthalmopathy
Diagnostisk test: MRI scan，ocular ultrasound
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
Diagnostisk test: MRI scan，ocular ultrasound
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai Changzheng Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

23. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TED-SCOPE-MR

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med MRI scan，ocular ultrasound

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