Characterizing Myositis With 68Ga-FAPI PET/CT
试验速览
- 阶段
- 早期 1 期
- 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 patients with IIM
研究概览
简要总结
To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis and evaluation of systemic involvement in idiopathic inflammatory myopathies (IIM)/myositis, and compared the results with those of 18F-FDG PET/CT.
详细描述
Inflammatory myopathies (IIM), collectively known as myositis, are heterogeneous systemic autoimmune disorders characterized by muscle inflammation, and frequently accompanied by extra-muscular manifestations that affect the skin, lung, and joints. Prevalence of underlying malignancy is high in patients with IIM.
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, and the potential utility of FAP-targeted PET/CT imaging for disease assessment in myositis have been reported in a case recently.
Thus, this prospective study is going to investigate utility of 68Ga-FAPI PET/CT in diagnosis, disease assessment including skeletal muscle involvement, cardiac involvement, interstitial lung diseases and potential underlying cancer screening, response to treatment and prognosis, compared with 18F-FDG PET/CT.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria
- •Adult men or women 18 and ≤ 75 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.
- •68Ga-FAPI and 18F-FDG PET/CT were performed within two weeks.
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.
研究组 & 干预措施
68Ga-FAPI
Inject 68Ga-FAPI and then perform PET/CT scan
干预措施: 68Ga-FAPI (Drug)
结局指标
主要结局
To define the distribution pattern of 68Ga-FAPI in patients with IIM
时间窗: 60 minutes following injection
To quantify 68Ga-FAPI positron emission tomography (PET) tracer biodistribution in diseased tissue including muscle, heart, lung and normal background organs. 68Ga-FAPI positron emission tomography (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 other parameters associated with disease activity(30 days)
- 68Ga-FAPI and disease progression(Up to 2 years)
- Therapy response(Up to 2 years)