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FAPI-PET/CT in Psoriatic Arthritis

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Enrolling
Early Phase 1

Conditions

Psoriatic Arthritis

Treatments

Drug: 68Ga-FAPI

Study type

Interventional

Funder types

Other

Identifiers

NCT05686876
LXM-230107

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

68Ga-FAPI, PET/CT
Experimental group
Description:
Inject 68Ga-FAPI and then perform PET/CT scan.
Treatment:
Drug: 68Ga-FAPI

Trial contacts and locations

1

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Central trial contact

Xiaomei Leng, MD

Data sourced from clinicaltrials.gov

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