FAPI-PET/CT in Psoriatic Arthritis

Study Overview
=================
Brief Summary
-----------------
68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation, such as IgG4-related disease. Therefore, this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for disease activity assessment and follow-up of psoriatic arthritis than 18F-NAF PET/CT.

Detailed Description
-----------------
Psoriatic arthritis (PsA) is a chronic inflammatory disease that develops in up to 30% of patients with psoriasis and characterized by diverse clinical features including peripheral and axial arthritis, enthesitis, dactylitis and nail dystrophy, leading to impaired function and reduced quality of life. Positron emission tomography (PET) allows for highly sensitive depiction of targets at the molecular level and can be used to specifically visualize immune cells of interest through the use of specific tracers. In this study, we used two tracers: 68Ga-fibroblast activation protein inhibitor (FAPI) and 18F-sodium fluoride (18F-NaF) to evaluate both joint inflammation and bone metabolism in patients with PsA. And the study is going to investigate whether 68Ga-FAPI PET/CT may be superior for disease activity assessment and follow-up of psoriatic arthritis than 18F-NAF PET/CT.

Official Title
-----------------
Fibroblast Activation Protein-Targeted PET/CT With 68Ga-FAPI for Imaging Psoriatic Arthritis: Comparison to 18F-NAF PET/CT

Conditions
-----------------
Psoriatic Arthritis

Intervention / Treatment
-----------------
* Drug: 68Ga-FAPI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fulfilled the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR) 18F-NAF PET/CT within two weeks signed written consent. Exclusion Criteria: pregnancy breast feeding known allergy against FAPI any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-FAPI, PET/CT<br>Inject 68Ga-FAPI and then perform PET/CT scan. | Drug: 68Ga-FAPI<br>* Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of PsA by PET/CT.<br>* Other names: 68Ga-fibroblast activating protein inhibitors;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic value | Diagnostic value of 68Ga-FAPI PET/CT for PsA in comparison with 18F-FDG PET/CT. | Through study completion, an average of 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity assessment | Correlation between disease activity assessed on 68Ga-FAPI PET/CT and clinical parameters for PsA. | Through study completion, an average of 3months. |