A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- 18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms
研究概览
简要总结
The aim of this study is to investigate the clinical value of [18F]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-octreotide（18F-AlF-NOTA-octreotide ） positron emission tomography / computed tomography (PET/CT) in patients with neuroendocrine neoplasms (NENs).
详细描述
18F-AlF-NOTA-octreotide is a radioligand targeting the somatostatin receptor, which is widely expressed on the cell surface of NENs. The radioligand can be used for the diagnosis and stage of the NENs. A total of 5 volunteers and 60 NEN patients will be subjected to a 18F-AlF-NOTA-octreotide PET/CT scan. The uptake of 18F-AlF-NOTA-octreotide in organs and tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologically and/or clinically confirmed and/or suspicious of NEN.
- •Signed informed consent.
排除标准
- •Claustrophobia (unable to accept PET/CT scanning)
- •Pregnant or breast-feeding
研究组 & 干预措施
18F-AlF-NOTA-octreotide PET/CT
One injection of the radioligand 18F-AlF-NOTA-octreotide
干预措施: 18F-AlF-NOTA-octreotide (Drug)
18F-AlF-NOTA-octreotide PET/CT
One injection of the radioligand 18F-AlF-NOTA-octreotide
干预措施: PET/CT (Device)
结局指标
主要结局
18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms
时间窗: 12 months
The radioligand 18F-AlF-NOTA-octreotide can be used to visualize neuroendocrine neoplasms
次要结局
- 18F-AlF-NOTA-octreotide PET/CT prognostic factor for overall and disease specific survival(24 months)