18F-FAPI PET/CT and 18F-FDG PET/CT in Patients With Pancreatic Adenocarcinoma : A Prospective, Single-Center, Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Diagnostic value
研究概览
简要总结
To explore the potential efficacy of 18F-FAPI-04 PET/CT for PDAC tumour staging and compare the results with those obtained using 18F-FDG PET/CT.
详细描述
Accurate diagnosis and staging are crucial for selecting treatment for patients with pancreatic ductal adenocarcinoma (PDAC). The desmoplastic responses associated with PDAC are often characterised by hypometabolism. Here we investigated 18F-fibroblast activation protein inhibitor (18F-FAPI-04) positron emission tomography/computed tomography (PET/CT) in evaluation of PDAC, and compared the findings with those obtained using (18F)-fluorodeoxyglucose (18F-FDG).
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
- •patients who were suspected to have PDAC by radiological imaging patients who underwent paired 18F-FAPI-04 PET/CT and 18F-FDG PET/CT for metastasis screening, recurrence confirmation, or tumour staging patients who were willing to participate in clinical trials and signed an informed consent form.
排除标准
- •patients with a history of severe contrast allergy pregnant patients patients who were not pathologically diagnosed as showing PDAC.
研究组 & 干预措施
Experimental
Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan
干预措施: 18F-FAPI (Drug)
Experimental
Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan
干预措施: 18F-FDG (Drug)
结局指标
主要结局
Diagnostic value
时间窗: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Sensitivity and Specificity of 18F-FAPI PET/CT for diagnosis and staging in comparison with 18F-FDG PET/CT
Maximum standardized uptake value
时间窗: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
SUVmax of 18F-FAPI PET/CT for lesions in comparison with 18F-FDG PET/CT
次要结局
- Diagnostic efficacy for primary lesions(1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT))
- SUVmax for lymph node(1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT))
- SUVmax for distant metastasis(1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT))
- Correlation between the SUVmax of 18F-FAPI and 18F-FDG uptake in patients with different treatment response(at least 2 months after treatment)
- SUVmax for primary lesions(1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT))
研究者
TingBo Liang
Professor
Zhejiang University