FAPI-PET/CT in Psoriatic Arthritis

Early Phase 1

Recruiting

• Conditions: Psoriatic Arthritis
• Interventions: Drug: 68Ga-FAPI

• Registration Number: NCT05686876
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2022-11-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-07
• Study First Submitted QC: 2023-01-07
• Last Update Submitted: 2023-01-07
• Study First Posted: 2023-01-17
• Last Update Posted: 2023-01-17
• Primary Completion: 2023-01-31
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI, PET/CT	68Ga-FAPI	Inject 68Ga-FAPI and then perform PET/CT scan.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences & Peking Union Medical College; 🇨🇳 Beijing, Beijing, China