Thyroid Eye DiseaseNCT07835607
Comparative Evaluation of 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MRI in Thyroid Eye Disease
An observational study of Thyroid Eye Disease, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- 68Ga-FAPI PET/CT and PET/MR Imaging and 68Ga-DOTATATE PET/CT and PET/MR Imaging
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2025to 31 Dec 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- For the thyroid eye disease cohort: diagnosis of thyroid eye disease according to European Group on Graves' Orbitopathy criteria.
- For the thyroid eye disease cohort: scheduled to undergo 68Ga-FAPI PET/CT and PET/MR and 68Ga-DOTATATE PET/CT and PET/MR within one week.
- For the control cohort: clinically recommended to undergo FAPI or somatostatin receptor PET imaging for another reason, with no history of thyroid-related disease or orbital disease; orbital PET/MR is added to the existing examination without additional radiation exposure.
Who cannot join
- Previous bilateral orbital surgery.
- Treatment with glucocorticoids, monoclonal antibodies, or radiotherapy within the previous month.
- Inability to remain supine.
- Contraindication to MRI, including incompatible metallic implants or claustrophobia.
- Planning pregnancy, currently pregnant, or breastfeeding.
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
Daping Hospital
Chongqing, Chongqing Municipality, 400010
Xiao Chen, PH.D, 15922970174, xiaochen229@tmmu.edu.cn
About this study
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.
Read the detailed description
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.
- Conditions
- Thyroid Eye Disease
- Being tested
- 68Ga-FAPI PET/CT and PET/MR Imaging, 68Ga-DOTATATE PET/CT and PET/MR Imaging
- Keywords
- FAPI, SSTR, PET, Thyroid Eye Disease
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI PET/CT and PET/MR ImagingDiagnostic test
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.
68Ga-DOTATATE PET/CT and PET/MR ImagingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Thyroid Eye Disease Cohort | 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. Receives: Diagnostic Test: 68Ga-FAPI PET/CT and PET/MR Imaging; Diagnostic Test: 68Ga-DOTATATE PET/CT and PET/MR Imaging | |
| Group 2 Control Cohort | 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. Receives: Diagnostic Test: 68Ga-FAPI PET/CT and PET/MR Imaging; Diagnostic Test: 68Ga-DOTATATE PET/CT and PET/MR Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At each imaging examination performed within the protocol-defined 1-week imaging period
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At each imaging examination performed within the protocol-defined 1-week imaging period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start14 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Chen, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835607
- Sponsor's protocol ID
- 2025480
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MRI in Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT07835607
- Acronym / sponsor ID
- 2025480
- Conditions
- Thyroid Eye Disease
- Keywords
- FAPI, SSTR, PET, Thyroid Eye Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Sep 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Thyroid Eye Disease Cohort | – | Diagnostic Test: 68Ga-FAPI PET/CT and PET/MR Imaging, Diagnostic Test: 68Ga-DOTATATE PET/CT and PET/MR ImagingAdults 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. |
| Group 2 Control Cohort | – | Diagnostic Test: 68Ga-FAPI PET/CT and PET/MR Imaging, Diagnostic Test: 68Ga-DOTATATE PET/CT and PET/MR ImagingAdults 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- For the thyroid eye disease cohort: diagnosis of thyroid eye disease according to European Group on Graves' Orbitopathy criteria.
- For the thyroid eye disease cohort: scheduled to undergo 68Ga-FAPI PET/CT and PET/MR and 68Ga-DOTATATE PET/CT and PET/MR within one week.
- For the control cohort: clinically recommended to undergo FAPI or somatostatin receptor PET imaging for another reason, with no history of thyroid-related disease or orbital disease; orbital PET/MR is added to the existing examination without additional radiation exposure.
Key exclusion criteria (5 listed)
- Previous bilateral orbital surgery.
- Treatment with glucocorticoids, monoclonal antibodies, or radiotherapy within the previous month.
- Inability to remain supine.
- Contraindication to MRI, including incompatible metallic implants or claustrophobia.
- Planning pregnancy, currently pregnant, or breastfeeding.
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 |
|---|---|---|
| 68Ga-FAPI PET/CT and PET/MR ImagingParticipants 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. | Diagnostic test | Group 1 Thyroid Eye Disease Cohort, Group 2 Control Cohort |
| 68Ga-DOTATATE PET/CT and PET/MR ImagingParticipants 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. | Diagnostic test | Group 1 Thyroid Eye Disease Cohort, Group 2 Control Cohort |
Primary outcome
Extraocular Muscle SUVmax on 68Ga-FAPI and 68Ga-DOTATATE PET Imaging
Time frame: At each imaging examination performed within the protocol-defined 1-week imaging period
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.
Extraocular Muscle Target-to-Background Ratio on 68Ga-FAPI and 68Ga-DOTATATE PET Imaging
Time frame: At each imaging examination performed within the protocol-defined 1-week imaging period
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.
3 secondary outcomes
Diagnostic Accuracy for Thyroid Eye Disease Activity
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
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
Time frame: At each imaging examination performed within the protocol-defined 1-week imaging period
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 23 Sep 2026.
- Individual participant dataSharing planned: No
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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 Thyroid Eye Disease, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University 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 3 inclusion and 5 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 23 Sep 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 Xiao Chen, PH .D (15922970174, xiaochen229@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extraocular Muscle SUVmax on 68Ga-FAPI and 68Ga-DOTATATE PET Imaging (time frame: At each imaging examination performed within the protocol-defined 1-week imaging period). The study lists 2 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 23 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.