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NCT Number: NCT07716397

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

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.

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Key information

Conditions

Graves Ophthalmopathy Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Associated Ophthalmopathies Thyroid Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Changzheng Hospital

Shanghai, Huangpu District, 200003, China

Location status: Recruiting

Location contact

Jian Zhou, MD

SUB_INVESTIGATOR

Jingmin Feng, MD

SUB_INVESTIGATOR

Lianqun Wu, MD

SUB_INVESTIGATOR

Tuo Li, MD

CONTACT

[email protected]

+86-13918507887

Tuo Li, MD

PRINCIPAL_INVESTIGATOR

Wei-yi Zhou, MD

CONTACT

[email protected]

+86-18689756502

Weiyi Zhou, MD

SUB_INVESTIGATOR

Xiaoyun Feng, MD

SUB_INVESTIGATOR

Yongquan Shi, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Diagnostic accuracy (AUC) of the AI model for TED

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

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

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Tuo Li, Vice Professor

CONTACT

[email protected]

+86-13918507887

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Registry information

Official study title

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

Acronym: TED-SCOPE-MR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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