FAPI-PET/CT in Psoriatic Arthritis
Primary Purpose
Psoriatic Arthritis
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI
Sponsored by
About this trial
This is an interventional screening trial for Psoriatic Arthritis
Eligibility Criteria
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.
Sites / Locations
- Chinese Academy of Medical Sciences & Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-FAPI, PET/CT
Arm Description
Inject 68Ga-FAPI and then perform PET/CT scan.
Outcomes
Primary Outcome Measures
Diagnostic value
Diagnostic value of 68Ga-FAPI PET/CT for PsA in comparison with 18F-FDG PET/CT.
Secondary Outcome Measures
Disease activity assessment
Correlation between disease activity assessed on 68Ga-FAPI PET/CT and clinical parameters for PsA.
Full Information
NCT ID
NCT05686876
First Posted
January 7, 2023
Last Updated
January 7, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05686876
Brief Title
FAPI-PET/CT in Psoriatic Arthritis
Official Title
Fibroblast Activation Protein-Targeted PET/CT With 68Ga-FAPI for Imaging Psoriatic Arthritis: Comparison to 18F-NAF PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-FAPI, PET/CT
Arm Type
Experimental
Arm Description
Inject 68Ga-FAPI and then perform PET/CT scan.
Intervention Type
Drug
Intervention Name(s)
68Ga-FAPI
Other Intervention Name(s)
68Ga-fibroblast activating protein inhibitors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic value
Description
Diagnostic value of 68Ga-FAPI PET/CT for PsA in comparison with 18F-FDG PET/CT.
Time Frame
Through study completion, an average of 3months
Secondary Outcome Measure Information:
Title
Disease activity assessment
Description
Correlation between disease activity assessed on 68Ga-FAPI PET/CT and clinical parameters for PsA.
Time Frame
Through study completion, an average of 3months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomei Leng, MD
Phone
+8615811217379
Email
lpumch@126.com
Facility Information:
Facility Name
Chinese Academy of Medical Sciences & Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaomei Leng
Phone
+8613681057089
Email
lpumch@126.com
12. IPD Sharing Statement
Learn more about this trial
FAPI-PET/CT in Psoriatic Arthritis
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