FAPI-PET/CT in Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686876
• Other study ID #: LXM-230107
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: January 2023
• Source: Peking Union Medical College Hospital
• Contact: Xiaomei Leng, MD
• Phone: +8615811217379
• Email: lpumch[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 28, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• 68Ga-FAPI
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.

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences & Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.