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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years;

Patients diagnosed with TED;

Complete understanding and voluntary participation in this study, with the signing of an informed consent form.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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

    Diagnostic test

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Experimental armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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