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

Thyroid Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06359795
• Other study ID #: FAPI-TED
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: Peking University Third Hospital
• Contact: Hui Li, Dr.
• Phone: 86-13121136769
• Email: huilee1990[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

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.

Locations

Country	Name	City	State
China	Dept. of Nuclear Medicine, Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	The accuracy of 18F-AlF-FAPI PET/CT in assessing the activity of TED.	through study completion, an average of 6 months
Secondary	The value to predict therapy response	The changes of SUV metrics on 18F-AlF-FAPI PET/CT to predict therapy response	through study completion, an average of 12 months
Secondary	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.	through study completion, an average of 6 months
Secondary	FAPI expression and SUV metrics	Correlation between SUV metrics on PET and FAPI expression in patients with surgery.	through study completion, an average of 12 months