Characterizing Spondyloarthritis With 68Ga-FAPI PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To define the distribution pattern of 68Ga-FAPI in SpA patients.
研究概览
简要总结
To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis, inflammation evaluation and prognosis prediction in spondyloarthritis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of SpA according to the ASAS (Assessment of Spondyloarthritis International Society) classification criteria for SpA.
- •Adult men or women 18 and ≤ 65 years of age at the time of signing the informed consent (ICF).
- •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.
排除标准
- •Breastfeeding;
- •known allergy against FAPI;
- •any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
结局指标
主要结局
To define the distribution pattern of 68Ga-FAPI in SpA patients.
时间窗: 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)).
次要结局
- Correlation between uptake of 68GA-FAPI and therapy response(Up to 2 years)
- Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity.(30 days)
- Correlation between uptake of 68GA-FAPI change and disease activity change(Up to 2 years)