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FAPI-PET/CT in Psoriatic Arthritis

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05686876
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
3.9
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Fibroblast Activation Protein-Targeted PET/CT With 68Ga-FAPI for Imaging Psoriatic Arthritis: Comparison to 18F-NAF PET/CT
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-FAPI, PET/CT

Inject 68Ga-FAPI and then perform PET/CT scan.

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.
Other Names:
  • 68Ga-fibroblast activating protein inhibitors

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese Academy of Medical Sciences & Peking Union Medical College Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05686876
    Other Study ID Numbers:
    • LXM-230107
    First Posted:
    Jan 17, 2023
    Last Update Posted:
    Jan 17, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Psoriatic

    Study Results

    No Results Posted as of Jan 17, 2023