NCT07835607From ClinicalTrials.govRecruiting

Comparative Evaluation of 68Ga-FAPI and 68Ga-DOTATATE PET/CT and PET/MRI in Thyroid Eye Disease

Thyroid Eye Disease

At a glance

Phase: Phase not stated
Study type: Observational
Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Enrolment target: 50
Started: 14 November 2025
Main results due: 31 December 2027
Study sites: 1
Registry updated: 23 September 2026

Can you take part?

Ages 18 years to 75 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

Daping Hospital
Chongqing, Chongqing Municipality, China
Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07835607. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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