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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
MRI scan,ocular ultrasound
Diagnostic testParticipants 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
Trial outcomes
Primary outcomes
Diagnostic accuracy (AUC) of the AI model for TED
using comprehensive clinical diagnosis (Bartley criteria) as the gold standard.
Classification accuracy of the AI model for distinguishing active versus inactive TED
Classification accuracy of the AI model for distinguishing mild versus moderate to severe TED
Secondary outcomes
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AI model.
Inter-observer agreement (Kappa coefficient) between the AI model and clinical experts.
Correlation (Pearson/Spearman correlation) between imaging features and pathological indicators .
Predictive performance of the AI model for treatment response, assessed by comparing baseline and follow-up ultrasound data.
Sponsors and contacts
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