Characterizing Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) With 68Ga-FAPI PET/CT
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Diagnostic value
研究概览
简要总结
68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of SAPHO than 18F-FDG PET/CT.
详细描述
Synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome is a spectrum of heterogeneous diseases characterized by osteoarticular and dermatological manifestations. Inflammatory osteitis with hyperostosis is the central feature of the syndrome, typically affecting multiple areas and possibly progressing to irreversible osteoarticular damage. Owing to the relapsing-remitting disease course, the goal of management is to improve clinical symptoms and prevent disease progression. Therefore, it's meaningful to seek appropriate methods to evaluate current osteroarticular lesions. 68Ga-FAPI that targets fibroblast activation protein (FAP) is introduced in tumor imaging. However, FAP was also shown to be expressed in rheumatoid arthritis, bone lesions with acute to chronic inflammation, fibrosis and ischemic heart tissue after myocardial infarction, thus the investigators speculate that it is possible for SAPHO to be imaged with 68Ga-FAPI. The aim of this study is to evaluate the performance of 68Ga-FAPI PET/CT in SAPHO and to compare it with the performance of 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected or confirmed untreated SAPHO patients;
- •18F-FDG PET/CT within two weeks;
- •signed written consent.
排除标准
- •pregnancy;
- •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 PET/CT
Inject 68Ga-FAPI and then perform PET/CT scan.
干预措施: 68Ga-FAPI (Drug)
结局指标
主要结局
Diagnostic value
时间窗: through study completion, an average of 1 year
Sensitivity and Specificity of 68Ga-FAPI PET/CT for SAPHO in comparison with 18F-FDG PET/CT
次要结局
- Metabolic parameters(through study completion, an average of 1 year)
- FAPI expression and SUV(through study completion, an average of 1 year)
- Disease burden assessement(through study completion, an average of 1 year)