Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/ CT in Patients with Orbital Neoplasms and Compared with 18F-FDG PET/ CT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 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-AlF-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in orbital neoplasms, and compared with 18F-FDG PET/CT.
详细描述
Subjects with orbital neoplasms underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT for initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of metastatic lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 18F-AlF-FAPI, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.
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
- 3 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with suspected or newly diagnosed orbital neoplasms (supporting evidence may include MRI, CT and pathology report);
- •patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans;
- •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 pregnancy;
- •breastfeeding;
- •the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
研究组 & 干预措施
Experimental arm
Experimental arm
干预措施: 18F-AlF-FAPI PET/CT, 18F-FDG PET/CT (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy
时间窗: through study completion, an average of 6 months
The diagnostic accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.
次要结局
- SUV metrics(through study completion, an average of 6 months)
- Tumor-to-background ratio(through study completion, an average of 6 months)
- Number of lesions(through study completion, an average of 6 months)