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

Peking University Third Hospital50 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Thyroid Eye Disease

Interventions

18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CTDIAGNOSTIC_TEST

Patients underwent 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT scans within 10 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 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.

Locations (1)

Dept. of Nuclear Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Diagnostic accuracy

The accuracy of 18F-AlF-FAPI PET/CT in assessing the activity of TED.

Time frame: through study completion, an average of 6 months

Secondary Outcomes

The value to predict therapy response

The changes of SUV metrics on 18F-AlF-FAPI PET/CT to predict therapy response

Time frame: through study completion, an average of 12 months

Diagnostic accuracy comparison

Comparing the diagnostic accuracy in assessing the activity of TED activity between 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT.

Time frame: through study completion, an average of 6 months

FAPI expression and SUV metrics

Correlation between SUV metrics on PET and FAPI expression in patients with surgery.

Time frame: through study completion, an average of 12 months

Central Contacts

Hui Li, Dr.

CONTACT

86-13121136769 huilee1990@163.com

Lingge Suo, Dr.

CONTACT

86-010-82264935 suolingge_1019@126.com

Data from ClinicalTrials.gov

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