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临床试验/NCT04514614
NCT04514614Unknown早期 1 期

Characterizing Rheumatoid Arthritis With 68Ga-FAPI PET/CT

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
100
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, such as IgG4-related disease and inflammatory bowel disease. Some researches identified FAP expression in synovial samples taken from both rheumatoid arthritis and osteoarthritis patients.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 arthritis than 18F-FDG PET/CT.

详细描述

Arthritis is a term used to mean any disorder that affects the joints. The two most common forms of arthritis are osteoarthritis and rheumatoid arthritis.Rheumatoid arthritis is an autoimmune chronic inflammatory disease of unknown etiology and is characterized by chronic inflammation of the joint capsule's synovial membrane. This chronic inflammation ultimately destroys the underlying cartilage and bone. Activated fibroblast-like synoviocytes (FLS) line the synovial membrane and are a prominent cell type responsible for inflammation and joint destruction. Osteoarthritis is characterized by degradation of joint cartilage. Studies demonstrate chondrocytes expressed FAP and that chondrocyte FAP expression was elevated in patients with osteoarthritis. Other researches identified FAP expression in synovial samples taken from both rheumatoid arthritis and osteoarthritis patients. However, FAP expression was greater in samples taken from refractory rheumatoid arthritis patients in comparison to end-stage osteoarthritis patients.68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation, such as IgG4-related disease and inflammatory bowel disease. Recently the investigators have published an article of the application of 68Ga-FAPI in IgG4-related disease which showed it was more sensitive than FDG in detecting a certain type of inflammations. 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 arthritis than 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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suspected or confirmed untreated arthritis 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

Experimental

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 IgG4-RD in comparison with 18F-FDG PET/CT.

次要结局

  • Metabolic parameters(Time Frame: through study completion, an average of 1 year)
  • Disease burden assessement(through study completion, an average of 1 year)
  • FAPI expression and SUV(through study completion, an average of 1 year)
  • Therapy response(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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