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FAPI-PET/CT in Psoriatic Arthritis

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05686876
Enrollment
20
Registered
2023-01-17
Start date
2022-11-01
Completion date
2023-02-28
Last updated
2023-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

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.

Interventions

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.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic valueThrough study completion, an average of 3monthsDiagnostic value of 68Ga-FAPI PET/CT for PsA in comparison with 18F-FDG PET/CT.

Secondary

MeasureTime frameDescription
Disease activity assessmentThrough study completion, an average of 3months.Correlation between disease activity assessed on 68Ga-FAPI PET/CT and clinical parameters for PsA.

Countries

China

Contacts

Primary ContactXiaomei Leng, MD
lpumch@126.com+8615811217379

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026