Prospective Clinical Study and Exploration of 18F-FAPI PET/CT Imaging in Cancers of Unknown Primary Site
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Diagnostic efficacy
研究概览
简要总结
This study aims to evaluate the diagnostic efficacy, therapeutic assessment, prognostic analysis, and impact on clinical treatment decisions of 18F-FAPI PET/CT in patients with cancer of unknown primary.
详细描述
Primary endpoint: Diagnostic efficacy of 18F-FAPI PET/CT in patients with undetermined primary tumor (sensitivity, specificity, accuracy).
secondary end points:
- The diagnostic performance of 18F-FAPI PET/CT compared with CT, MR and 18F-FDG PET in the clinical application of cancer with unknown primary site was compared.
④Assess the heterogeneity of sensitivity and specificity of 18F-FAPI PET/CT for different system sites (neck/thorax/abdomen).
- Study on efficacy evaluation and prognostic prediction of 18F-FAPI PET/CT in patients with primary tumors of unknown origin.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical or imaging suspicion of cancer of unknown primary origin.
- •Patients with 18F FAPI PET scans.
排除标准
- •Concurrent presence of other active malignant tumors or a history of other malignant tumors within the past 5 years;
- •Severe uncontrollable diseases or active infections;
- •Ineligible participants for project informed consent.
- •Pregnant and lactating women.
研究组 & 干预措施
FAPI-cups
FAPI PET scan in patients with CUPs
干预措施: 18F-FAPI PET (Diagnostic Test)
结局指标
主要结局
Diagnostic efficacy
时间窗: through study completion, an average of 1.5 year
Sensitivity, specificity, positive and negative predictive value of 18F-FAPI PET/CT Imaging in cancers of unknown primary site
次要结局
- Standard uptake value （SUV）of tumor(through study completion, 3-4 years)
- Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor(through study completion, 3-4 years)
- Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients(through study completion, 3-4 years)