Ankylosing Spondylitis Clinical Trial
Official title:
Characterizing Spondyloarthritis With 68Ga-FAPI PET/CT
To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis, inflammation evaluation and prognosis prediction in spondyloarthritis.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 1, 2025 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. A diagnosis of SpA according to the ASAS (Assessment of Spondyloarthritis International Society) classification criteria for SpA. 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: 1. Pregnancy; 2. Breastfeeding; 3. known allergy against FAPI; 4. any medical condition that in the opinion of the investigator may significantly interfere with study compliance. |
Country | Name | City | State |
---|---|---|---|
China | The first affiliated hospital of Xiamen University | Xiamen | Fujian |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Xiamen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To define the distribution pattern of 68Ga-FAPI in SpA patients. | To quantify 68Ga-FAPI tracer biodistribution in characteristic inflammatory tissue including SI joints, spine, and the peripheral joints versus conventional x ray examination or magnetic resonance imaging (MRI) techniques in adult active SpA. 68Ga-FAPI PET tracer biodistribution will be assessed by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)). | 60 minutes following injection | |
Secondary | Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity. | Correlation between uptake of 68GA-FAPI and parameters associated with disease activity including Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath ankylosing spondylitis disease activity index (BSADAI), Bath ankylosing spondylitis functional index (BASFI),and Maastricht Ankylosing Spondylitis Enthesitis Score(MASES). The Standardized uptake value (SUV) of 68Ga-FAPI was calculated and analyzing the correlation between pathological results and parameters associated with disease activity. | 30 days | |
Secondary | Correlation between uptake of 68GA-FAPI change and disease activity change | Correlation between change in standardized uptake value (SUV) of 68Ga-FAPI at inflammatory site with change in Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath ankylosing spondylitis disease activity index (BSADAI), Bath ankylosing spondylitis functional index (BASFI),and Maastricht Ankylosing Spondylitis Enthesitis Score(MASES) at different disease stage. | Up to 2 years | |
Secondary | Correlation between uptake of 68GA-FAPI and therapy response | Percentage of participants achieving ankylosing spondylitis disease activity score inactive disease [ASDAS ID (<1.3)] after 1 year standardized treatment in participants with high standardized uptake value (SUV) of 68Ga-FAPI and low standardized uptake value (SUV) of 68Ga-FAPI at baseline. | Up to 2 years |
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