Thyroid Eye Disease Clinical Trials

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Construction and Optimization of a Multimodal Orbital MRI-AI Model and Its Application in Thyroid Eye Disease: A National Multicenter Registry Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Shanghai Changzheng Hospital
RECRUITING
Shanghai
Contact Information
Primary
Tuo Li, Vice Professor
zoe_leeto@hotmail.com
+86-13918507887
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 1200
Treatments
TAO
Participants with Thyroid Associated Ophthalmopathy
Normal
healthy individuals without thyroid-associated ophthalmopathy
Sponsors
Leads: Shanghai Changzheng Hospital

This content was sourced from clinicaltrials.gov