Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT.
- Who it may be relevant to
- Registry conditions: Thyroid Eye Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET/CT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET/CT may be superior to 99mTc-DTPA SPECT/CT for the diagnosis, therapy response assessment, and follow-up of TED.
Detailed description
Subjects with TED underwent 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT for activity assessment within a 10-day period. On 18F-AlF-FAPI PET/CT, uptake in the extraocular muscles was quantified using SUV metrics and target-to-background ratio. On 99mTc-DTPA SPECT/CT, uptake in the extraocular muscles was semi-quantified using the uptake ratio. Activity of TED was determined through comprehensive clinical data. The correlation between SUV metrics and activity status was calculated to explore the value of 18F-AlF-FAPI PET/CT in assessing TED activity. The diagnostic accuracy of 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT in assessing TED activity was compared. Additionally, the correlation of changes in SUV metrics and therapy response will be calculated to explore the value of 18F-AlF-FAPI PET/CT in therapy response assessment of TED.
Interventions
- Diagnostic test 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT
Patients underwent 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT scans within 10 days.
Primary outcome measures
- Diagnostic accuracy [Time frame: through study completion, an average of 6 months]
Secondary outcome measures (3)
- The value to predict therapy response [Time frame: through study completion, an average of 12 months]
- Diagnostic accuracy comparison [Time frame: through study completion, an average of 6 months]
- FAPI expression and SUV metrics [Time frame: through study completion, an average of 12 months]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years;
- Patients diagnosed with TED;
- Complete understanding and voluntary participation in this study, with the signing of an informed consent form.
Exclusion criteria
- Severe liver or kidney dysfunction;
- Inability to maintain a supine position for 5 minutes to cooperate with the examination;
- Suffering from claustrophobia or other psychiatric disorders;
- Patients planning pregnancy or in the prenatal or lactation period;
- Other conditions deemed unsuitable for participation in the trial by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Dept. of Nuclear Medicine, Peking University Third Hospital — Beijing
Identifiers
NCT: NCT06359795 · FAPI-TED