Imaging Comparison of 68Ga-FAPI and 68Ga-DOTATATE in Thyroid Eye Disease
Official title: Comparative Evaluation of 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MRI in Thyroid Eye Disease
Run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · NCT07835607 · Data updated 2026-11-12
This study tests two PET imaging methods (FAPI and DOTATATE) to see which best images activity in the eyes of adults with thyroid eye disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Status | Recruiting |
| Started | November 14, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT07835607 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 75 with thyroid eye disease who are scheduled for both imaging approaches within one week.
✕Probably not a fit
Patients without thyroid eye disease or without the indicated imaging could see no benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this prospective, single-center cohort, adults with thyroid eye disease and a disease-free control group will undergo both 68Ga-FAPI PET/CT and PET/MR and 68Ga-DOTATATE PET/CT and PET/MR within a week. Nuclear medicine physicians will assess whether uptake in the extraocular muscles is present and quantify it using metrics like SUV and target-to-background ratio, then relate imaging findings to clinical activity and muscle thickness. The study uses blinded image interpretation and standard imaging protocols, with MRI sequences included in PET/MR. The goal is to characterize and compare the two tracer approaches, alone and in combination, for activity assessment in thyroid eye disease.
Why it matters
Potential benefit: If successful, this could refine how disease activity is imaged and tracked, potentially guiding treatment decisions.
How similar studies have gone: Previous work has explored similar PET tracers in related orbital/inflammatory conditions, but direct comparison in thyroid eye disease is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
Daping Hospital
Chongqing, Chongqing Municipality, China Recruiting
Study contacts
- Study coordinator: Xiao Chen, PH .D
- Email: xiaochen229@tmmu.edu.cn
- Phone: 15922970174
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.