Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04 and 18F-FDG PET-CT
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Diagnostic value
研究概览
简要总结
68Ga-fibroblast activating protein inhibitors(FAPI) has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research. 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 Pulmonary fibrosis than 18F-FDG PET/CT.
详细描述
Pulmonary fibrosis is a prototype of chronic, progressive, and fibrotic lung disease.Healthy tissue is replaced by altered extracellular matrix and alveolar architecture is destroyed, which leads to decreased lung compliance, disrupted gas exchange, and ultimately respiratory failure and death.Pulmonary fibrosis is diagnosed by identification of a pattern of usual interstitial pneumonia on the basis of radiological or histological criteria in patients without evidence of an alternative cause. Activated fibroblasts are crucial for fibrotic processes in Pulmonary fibrosis. 68Ga-FAPI has been developed as a tumortargeting agent as fibroblast activation protein is overexpressed in cancerassociated fibroblasts and inflammation. Recently，a study shows that FAPI-PET/CT imaging is a promising new imaging modality for Pulmonary fibrosis.This head-to-head comparisons aims to evaluate the severity of pulmonary fibrosis and the therapy response of 68Ga-FAPI-04 compared with 18F-FDG in the same group of pulmonary fibrosis patients.
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 pulmonary fibrosis patients;
- •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-04 PET/CT and 18F-FDG PET/CT
All patients diagnosed with Lung fibrosis underwent 68Ga-FAPI PET/CT and 18F-FDG PET/CT.
干预措施: 68Ga-FAPI (Drug)
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
All patients diagnosed with Lung fibrosis underwent 68Ga-FAPI PET/CT and 18F-FDG PET/CT.
干预措施: 18F-FDG (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 Lung fibrosis in comparison with 18F-FDG PET/CT
次要结局
- FAPI expression and SUV(through study completion, an average of 1 year)
- therapy response(through study completion, an average of 1 year)