Characterizing Spondyloarthritis With 68Ga-FAPI PET/CT

Not Applicable

Recruiting

• Conditions: Ankylosing Spondylitis; Axial Spondyloarthritis; Spondyloarthritis

• Registration Number: NCT05999643
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief Summary

To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis, inflammation evaluation and prognosis prediction in spondyloarthritis.

Detailed Description

Spondyloarthritis (SpA) is a chronic inflammatory rheumatic disease characterized by inflammatory back pain, enthesitis, dactylitis, and the formation of syndesmophytes, all of which significantly affect a patient's healthy functioning and general quality of life. Prevalence of underlying malignancy is high in patients with SpA. Radiographic sacroiliitis became a crucial finding in the diagnosis and classification of patients.

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.

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-01
• Study First Submitted: 2023-07-30
• Study First Submitted QC: 2023-08-13
• Last Update Submitted: 2023-08-13
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21
• Primary Completion: 2024-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To define the distribution pattern of 68Ga-FAPI in SpA patients.	60 minutes following injection	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)).

Secondary Outcome Measures

Name	Time	Method
Correlation between uptake of 68GA-FAPI and therapy response	Up to 2 years	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.
Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity.	30 days	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.
Correlation between uptake of 68GA-FAPI change and disease activity change	Up to 2 years	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.

Trial Locations

Locations (1)

The first affiliated hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China