The Performance of 18F-FAPI PET/CT in Patients With Various Types of Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
To evaluate the potential usefulness of 18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.
详细描述
Subjects with various types of cancer underwent 18F-FAPI PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). Using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FAPI PET/CT were calculated.
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 with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
- •patients who had scheduled 18F-FAPI PET/CT scan; (iv)
- •patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
排除标准
- •patients with non-malignant lesions;
- •patients with pregnancy;
- •the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
研究组 & 干预措施
18F-FAPI
Experimental: Experimental: 18F-FAPI Each subject receive a single intravenous injection of 18F-FAPI, and undergo PET/CT imaging within the specificed time.
干预措施: 18F-FAPI (Drug)
结局指标
主要结局
Diagnostic accuracy
时间窗: 1 year
The sensitivity, specificity and accuracy of 18F-FAPI PET/CT were calculated.
次要结局
未报告次要终点
研究者
Ji Bin
Doctor
Jilin University