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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06359795
Other study ID # FAPI-TED
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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