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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorShanghai Changzheng Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnant or lactating women.

Patients with other orbital lesions.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MRI scan,ocular ultrasound

    Diagnostic test

    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).

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: TAO1 intervention
Group B: Normal1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy (AUC) of the AI model for TED

using comprehensive clinical diagnosis (Bartley criteria) as the gold standard.

Time frame
From enrollment to the end of follow-up at 18 months
2

Classification accuracy of the AI model for distinguishing active versus inactive TED

Time frame
From enrollment to the end of follow-up at 18 months
3

Classification accuracy of the AI model for distinguishing mild versus moderate to severe TED

Time frame
From enrollment to the end of follow-up at 18 months

Secondary outcomes

1

Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AI model.

Time frame
From enrollment to the end of follow-up at 18 months
2

Inter-observer agreement (Kappa coefficient) between the AI model and clinical experts.

Time frame
From enrollment to the end of follow-up at 18 months
3

Correlation (Pearson/Spearman correlation) between imaging features and pathological indicators .

Time frame
From enrollment to the end of follow-up at 18 months
4

Predictive performance of the AI model for treatment response, assessed by comparing baseline and follow-up ultrasound data.

Time frame
From enrollment to the end of follow-up at 18 months

Other outcomes

Sponsors and contacts

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