Graves OphthalmopathyTED-SCOPE-MRNCT07716397
Screening, Classification, and Outcome Prediction Ensemble Using Orbital MRI for Thyroid Eye Disease: The TED SCOPE National Multicenter Registry Study
An observational study of Graves Ophthalmopathy and Graves Disease, run by Shanghai Changzheng Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Graves Ophthalmopathy, Graves Disease, Thyroid Associated Ophthalmopathies
- What is being tested?
- MRI scan，ocular ultrasound
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2028
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Huangpu District, 200003
Tuo Li, MD, +86-13918507887, zoe_leeto@hotmail.com
Wei-yi Zhou, MD, +86-18689756502, weiyizhou@smmu.edu.cn
About this study
Official title: Construction and Optimization of a Multimodal Orbital MRI-AI Model and Its Application in Thyroid Eye Disease: A 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.
- Being tested
- MRI scan，ocular ultrasound
- Keywords
- TED
- Medical subject headings
- Graves Ophthalmopathy, Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scan，ocular ultrasoundDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| TAO | Participants with Thyroid Associated Ophthalmopathy Receives: Diagnostic Test: MRI scan，ocular ultrasound | |
| Normal | healthy individuals without thyroid-associated ophthalmopathy Receives: Diagnostic Test: MRI scan，ocular ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy (AUC) of the AI model for TED
using comprehensive clinical diagnosis (Bartley criteria) as the gold standard.
Measured: From enrollment to the end of follow-up at 18 months
Classification accuracy of the AI model for distinguishing active versus inactive TED
Measured: 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
Measured: From enrollment to the end of follow-up at 18 months
Secondary outcomes (4)
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AI model.
Measured: From enrollment to the end of follow-up at 18 months
Inter-observer agreement (Kappa coefficient) between the AI model and clinical experts.
Measured: From enrollment to the end of follow-up at 18 months
Correlation (Pearson/Spearman correlation) between imaging features and pathological indicators .
Measured: 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.
Measured: From enrollment to the end of follow-up at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves OphthalmopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuo Li, MD, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716397
- Sponsor's protocol ID
- TED-SCOPE-MR
- Acronym
- TED-SCOPE-MR
- Status last verified
- Jul 2026
- First submitted
- 23 May 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Optimization of a Multimodal Orbital MRI-AI Model and Its Application in Thyroid Eye Disease: A National Multicenter Registry Study
- ClinicalTrials.gov ID
- NCT07716397
- Acronym / sponsor ID
- TED-SCOPE-MR / TED-SCOPE-MR
- Keywords
- TED
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAO | – | Diagnostic Test: MRI scan，ocular ultrasoundParticipants with Thyroid Associated Ophthalmopathy |
| Normal | – | Diagnostic Test: MRI scan，ocular ultrasoundhealthy individuals without thyroid-associated ophthalmopathy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (8 listed)
- TAO patient 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.
Key exclusion criteria (9 listed)
- TAO patient group:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scan，ocular ultrasoundParticipants 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 test | Normal, TAO |
Primary outcome
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.
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Ophthalmopathy and Graves Disease, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuo Li, Vice Professor (+86-13918507887, zoe_leeto@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (AUC) of the AI model for TED (time frame: From enrollment to the end of follow-up at 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.