Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2023-07-01
2025-08-01
Brief Summary
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Detailed Description
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68Ga-FAPI has been developed as tracers specific for fibroblast-activation protein (FAP), which is overexpressed in activated fibroblasts in various type of cancers and autoimmune diseases, such as rheumatoid arthritis, IgG4-related diseases and interstitial lung diseases.
Recently the investigators have published articles of the application of 68Ga-FAPI in IgG4-related disease and rheumatoid arthritis, which showed it was more sensitive than FDG in detecting a certain type of inflammation. Increased 68Ga-FAPI Uptake in ankylosing spondylitis in a patient with rectal cancer has also been reported in a case report, indicating the potential utility of FAP-targeted PET/CT imaging for diagnosis and disease assessment in spondyloarthritis.
Thus, this prospective study is going to investigate utility of 68Ga-FAPI PET/CT in diagnosis of spondyloarthritis as well as inflammation assessment in joints including the sacroiliac (SI) joints, spine and peripheral joints. Also, this study aims to investigate potential utility of 68Ga-FAPI PET/CT in predicting treatment response and disease prognosis such as formation of syndesmophytes and erosive changes.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Inject 68Ga-FAPI and then perform PET/CT scan.
Inject 68Ga-FAPI and then perform PET/CT scan
Drug: 68Ga-FAPI
Intravenous injection of one dosage of 111-185 MBq (3-5 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image SpA lesions in SI joints, spine, musculoskeletal and the extra-articular involvement by PET/CT.
Interventions
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Drug: 68Ga-FAPI
Intravenous injection of one dosage of 111-185 MBq (3-5 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image SpA lesions in SI joints, spine, musculoskeletal and the extra-articular involvement by PET/CT.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adult men or women 18 and ≤ 65 years of age at the time of signing the informed consent (ICF).
3. participants who were able to provide informed consent (signed by participant or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion Criteria
2. Breastfeeding;
3. known allergy against FAPI;
4. any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
18 Years
65 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Xiamen University
OTHER
Responsible Party
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Principal Investigators
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Guixiu Shi, PhD
Role: STUDY_DIRECTOR
The First Affiliated Hospital of Xiamen University
Locations
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The first affiliated hospital of Xiamen University
Xiamen, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Qiuwan Wu, PhD
Role: primary
References
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Chen Y, Yu L, Chen S, Liu W, Han H, Pang Y, Lin Q, Li Y, Chen L, Cai J, Zhao L, Sun L, Shi G, Chen H, Liu Y. Fibroblast activation protein-targeted PET/CT with 68Ga-FAPI-46 for evaluation of structural damage and inflammation in axial spondyloarthritis: a prospective study. Eur J Nucl Med Mol Imaging. 2025 Oct;52(12):4661-4673. doi: 10.1007/s00259-025-07310-2. Epub 2025 May 1.
Other Identifiers
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FAPI in SpA
Identifier Type: -
Identifier Source: org_study_id
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