Clinical trial NCT05999643: Characterizing Spondyloarthritis With 68Ga-FAPI PET/CT
Official title: Characterizing Spondyloarthritis With 68Ga-FAPI PET/CT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spondyloarthritis
Axial Spondyloarthritis
Ankylosing Spondylitis
Keywords: Spondyloarthritis
Axial Spondyloarthritis
Ankylosing Spondylitis
68Ga-FAPI
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To define the distribution pattern of 68Ga-FAPI in SpA patients.
timeFrame: 60 minutes following injection
Secondary outcomes:
measure: Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity.
timeFrame: 30 days
measure: Correlation between uptake of 68GA-FAPI change and disease activity change
timeFrame: Up to 2 years
measure: Correlation between uptake of 68GA-FAPI and therapy response
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The first affiliated hospital of Xiamen University
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital of Xiamen University
name: Guixiu Shi, PhD
role: STUDY_DIRECTOR
References: