Clinical trial Recruiting at 1 site Observational Ages 18 to 75

AI-based MRI and ultrasound for thyroid-related eye disease

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

Run by Shanghai Changzheng Hospital · NCT07716397 · Data updated 2026-11-12

This study tests an AI model using orbital MRI and eye ultrasound to help diagnose activity and severity of thyroid-associated ophthalmopathy and predict its course in adults.

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Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment1200 (estimated)
SponsorShanghai Changzheng Hospital
Academic / other
Locations1 site (Shanghai, Huangpu District)
StatusRecruiting
StartedJanuary 1, 2026
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedJuly 21, 2026
Trial IDNCT07716397 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 to 75 with thyroid-associated ophthalmopathy, at various stages, and healthy volunteers matched by age and gender.

Probably not a fit

Patients with contraindications to MRI, prior orbital surgery or radiotherapy (except some allowed cases), or other orbital lesions may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter observational study that prospectively validates an AI multimodal model built from orbital MRI sequences and ocular ultrasound for TAO. The study compares AI-driven assessments of presence, activity, severity, and prognosis between TAO patients and controls. Participants undergo standardized MRI scans including multiple sequences and receive ocular ultrasound, with data collected in real-world clinical settings. The goal is to determine how accurately the AI model can classify TAO status and forecast disease trajectory. Real-world applicability and diagnostic performance across diverse patients are central to the approach.

Why it matters

Potential benefit: If successful, the AI model could improve accuracy and speed of TAO diagnosis and prognosis, supporting more personalized management.

How similar studies have gone: Previous studies show promise for AI in imaging-based TAO assessment, but this specific multimodal MRI-plus-ultrasound approach in a real-world registry is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Shanghai Changzheng Hospital
    Shanghai, Huangpu District, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.