An observational study in Graves Ophthalmopathy, Graves Disease and Thyroid Associated Ophthalmopathies, sponsored by Shanghai Changzheng Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Shanghai Changzheng Hospital · Observational
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.
199 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 80 across 45 observational studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →Shanghai Changzheng Hospital is the lead sponsor of 128 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with Thyroid Associated Ophthalmopathy
Diagnostic Test: MRI scan，ocular ultrasound
healthy individuals without thyroid-associated ophthalmopathy
Diagnostic 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).
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
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
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
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
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
Correlation (Pearson/Spearman correlation) between imaging features and pathological indicators .
Time frame: 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.
Time frame: From enrollment to the end of follow-up at 18 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2028, 35 months after the start.
Of 20 observational studies under Graves Ophthalmopathy, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 59. This study's planned 35 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Changzheng Hospital →