Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease

Not Applicable

Recruiting

• Conditions: Thyroid Eye Disease
• Interventions: Diagnostic Test: 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT

• Registration Number: NCT06359795
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

Study Timeline

• Study Start: 2023-12-15
• Status Verified: 2024-04
• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-07
• Last Update Submitted: 2024-04-07
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age ≥ 18 years;
2. Patients diagnosed with TED;
3. Complete understanding and voluntary participation in this study, with the signing of an informed consent form.

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Exclusion Criteria

1. Severe liver or kidney dysfunction;
2. Inability to maintain a supine position for 5 minutes to cooperate with the examination;
3. Suffering from claustrophobia or other psychiatric disorders;
4. Patients planning pregnancy or in the prenatal or lactation period;
5. Other conditions deemed unsuitable for participation in the trial by the investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT	Patients with TED will be recruited in the study. Interventions: Diagnostic Test: 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	through study completion, an average of 6 months	The accuracy of 18F-AlF-FAPI PET/CT in assessing the activity of TED.

Secondary Outcome Measures

Name	Time	Method
The value to predict therapy response	through study completion, an average of 12 months	The changes of SUV metrics on 18F-AlF-FAPI PET/CT to predict therapy response
FAPI expression and SUV metrics	through study completion, an average of 12 months	Correlation between SUV metrics on PET and FAPI expression in patients with surgery.
Diagnostic accuracy comparison	through study completion, an average of 6 months	Comparing the diagnostic accuracy in assessing the activity of TED activity between 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT.

Trial Locations

Locations (1)

Dept. of Nuclear Medicine, Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China