An observational study in Thyroid Eye Disease, sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Observational
Thyroid eye disease is an autoimmune disorder that can cause inflammation and fibrosis of the extraocular muscles and orbital tissues. Accurate assessment of disease activity is important for treatment planning, but commonly used clinical scores and conventional imaging each have limitations.
This prospective single-center cohort study will evaluate two molecular imaging approaches, gallium-68-labeled fibroblast activation protein inhibitor (68Ga-FAPI) PET/CT and PET/MR and gallium-68 DOTATATE somatostatin receptor PET/CT and PET/MR, in adults with thyroid eye disease and in a control group without thyroid-related or orbital disease. The study will compare visual and quantitative imaging findings, including maximum standardized uptake value and target-to-background ratio in the extraocular muscles, and examine their associations with clinical activity score and extraocular muscle thickness. The study aims to characterize the ability of these imaging methods, separately and in combination, to assess thyroid eye disease activity.
This is a prospective, single-center cohort study planned to enroll approximately 50 adults aged 18 to 75 years. The thyroid eye disease cohort will include approximately 30 participants diagnosed according to European Group on Graves' Orbitopathy criteria. The control cohort will include approximately 20 participants without a history of thyroid-related or orbital disease who undergo clinically indicated FAPI or somatostatin receptor PET imaging for another reason; orbital PET/MR acquisition will be added to the existing examination without additional radiation exposure.
Participants in the thyroid eye disease cohort will undergo 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MR imaging within one week. For each tracer, imaging will begin approximately 50 minutes after intravenous administration of 3 to 5 mCi. PET/CT will include a CT acquisition for attenuation correction and anatomic localization followed by three-dimensional PET acquisition of the head for approximately 5 minutes per bed position. PET/MR will include simultaneous PET acquisition and routine MR sequences, including T1-weighted, T2-weighted, and FLAIR imaging. PET images will be reconstructed using an ordered-subset expectation maximization algorithm and fused with CT or MR images.
Nuclear medicine physicians will evaluate images without access to clinical data. Each eye will be visually classified as positive when any extraocular muscle demonstrates uptake greater than background and negative otherwise. For participant-level analysis, a participant will be considered positive when at least one eye is positive. Quantitative analysis will measure maximum standardized uptake value in the superior, medial, lateral, and inferior rectus muscles. A 1-cm region of interest in occipital soft tissue will be used as background. The target-to-background ratio will be calculated as extraocular muscle SUVmax divided by background SUVmax.
Clinical information collected from electronic medical records will include age, sex, disease duration, clinical diagnosis, treatment plan, and Clinical Activity Score. Imaging measures will be compared between groups and modalities and will be examined for associations with Clinical Activity Score and extraocular muscle thickness. Receiver operating characteristic analysis will be used to evaluate diagnostic accuracy.
199 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 45 observational studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 121 studies on the registry; 42 are open to participants now.
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Participants will be selected from adults evaluated in the Department of Nuclear Medicine at the Army Medical Center of PLA between November 2025 and December 2027. The thyroid eye disease cohort will consist of patients meeting European Group on Graves' Orbitopathy diagnostic criteria. The control cohort will consist of patients without thyroid-related or orbital disease who undergo clinically indicated FAPI or somatostatin receptor PET imaging for another reason.
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Exclusion Criteria:
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Adults diagnosed with thyroid eye disease according to European Group on Graves' Orbitopathy criteria. Participants undergo 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MR imaging within one week.
Diagnostic Test: 68Ga-FAPI PET/CT and PET/MR Imaging · Diagnostic Test: 68Ga-DOTATATE PET/CT and PET/MR Imaging
Adults without a history of thyroid-related or orbital disease who undergo clinically indicated FAPI or somatostatin receptor PET imaging for another reason. Orbital PET/MR acquisition is added to the existing examination without additional radiation exposure.
Diagnostic Test: 68Ga-FAPI PET/CT and PET/MR Imaging · Diagnostic Test: 68Ga-DOTATATE PET/CT and PET/MR Imaging
Participants receive 3 to 5 mCi of 68Ga-FAPI intravenously. PET/CT and PET/MR imaging of the head and orbits is performed approximately 50 minutes after injection, with PET acquisition of approximately 5 minutes per bed position. PET/MR includes routine T1-weighted, T2-weighted, and FLAIR sequences. The exact FAPI compound should be added if specified by the radiopharmacy documentation. Required confirmation: the protocol does not identify the specific FAPI compound, such as FAPI-04.
Participants receive 3 to 5 mCi of 68Ga-DOTATATE intravenously. PET/CT and PET/MR imaging of the head and orbits is performed approximately 50 minutes after injection, with PET acquisition of approximately 5 minutes per bed position. PET/MR includes routine T1-weighted, T2-weighted, and FLAIR sequences.
Extraocular Muscle SUVmax on 68Ga-FAPI and 68Ga-DOTATATE PET Imaging
Maximum standardized uptake value will be measured separately in the superior, medial, lateral, and inferior rectus muscles on PET/CT and PET/MR images for each tracer. Values will be summarized by tracer, imaging platform, eye, and participant group.
Time frame: At each imaging examination performed within the protocol-defined 1-week imaging period
Extraocular Muscle Target-to-Background Ratio on 68Ga-FAPI and 68Ga-DOTATATE PET Imaging
For each extraocular muscle, target-to-background ratio will be calculated as extraocular muscle SUVmax divided by background SUVmax measured using a 1-cm region of interest in occipital soft tissue. Values will be summarized by tracer, imaging platform, eye, and participant group.
Time frame: At each imaging examination performed within the protocol-defined 1-week imaging period
Diagnostic Accuracy for Thyroid Eye Disease Activity
Receiver operating characteristic curves will be used to estimate the area under the curve for quantitative 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MR measures in relation to clinically defined thyroid eye disease activity. Required confirmation: specify the reference standard and exact Clinical Activity Score threshold used to define active disease before submission.
Time frame: At completion of imaging and clinical activity assessment within the protocol-defined 1-week period
Association Between PET Uptake Measures and Clinical Activity Score
Pearson correlation coefficients will be used to assess associations of extraocular muscle SUVmax and target-to-background ratio with Clinical Activity Score.
Time frame: At completion of imaging and Clinical Activity Score assessment within the protocol-defined 1-week period
Association Between PET Uptake Measures and Extraocular Muscle Thickness
Pearson correlation coefficients will be used to assess associations of extraocular muscle SUVmax and target-to-background ratio with extraocular muscle thickness measured on anatomic imaging. Required confirmation: specify the sequence, measurement plane, muscle-specific rule, and unit for extraocular muscle thickness.
Time frame: At each imaging examination performed within the protocol-defined 1-week imaging period
Visual Positivity of Extraocular Muscle Uptake
Each eye will be classified as positive when any extraocular muscle demonstrates 68Ga-FAPI or 68Ga-DOTATATE uptake greater than background and negative otherwise. At participant level, a participant will be classified as positive when at least one eye is positive. Positivity will be compared between imaging approaches using categorical analyses.
Time frame: At each imaging examination performed within the protocol-defined 1-week imaging period
Plan to share: No
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Started Nov 2025 (actual). Primary completion is estimated for Dec 2027, 25 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 25 months is below that.
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University →