Diagnostic Efficacy of 18F-FAPI-74 PET/CT in Patients With Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 3) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph node metastasis and distant metastasis in patient level in patients with recurrent pancreatic cancer
研究概览
简要总结
Staging pancreatic cancer (PC) presents a clinical challenge. Triphasic whole body CT is the primary imaging method in diagnosing, staging and during follow up. Conventional PET/CT with 18F-labelled fluorodeoxyglucose (18F-FDG) has its limitations and therefore has a secondary role in imaging pancreatic cancer patients. These conventional imaging methods are good in detecting primary tumors and distant metastasis but poor in detecting local lymph node metastasis. A new PET tracer, fibroblast activation protein inhibitor (FAPI), targets FAP, a protein overexpressed in cancer-associated fibroblasts. It presents a potential new PET imagining tool.
The objective of this prospective diagnostic study is to evaluate the diagnostic efficacy of 18F-FAPI-74 PET/CT in patients with PC. The aim is to evaluate the sensitivity and specificity of 18F-FAPI-74 in detection of local lymph node metastasis and distant metastasis in patient level in patients with PC in primary staging and when suspected recurrence. 100 patients with PC are enrolled on whom PET/CT studies are performed with the novel 18F-FAPI-74 tracer. The data will be collected between 2024-2026.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected primary or recurrent pancreatic cancer
- •Subjects must be male or female aged 18-85 years.
- •WHO performance score 0-
- •Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
排除标准
- •Vulnerable study subjects such as described in Finnish law clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included.
- •Study subject is not able to understand the purpose of the study.
- •Medical conditions prohibiting whole-body PET/CT imaging.
研究组 & 干预措施
Staging
干预措施: PET/CT (Device)
结局指标
主要结局
3) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph node metastasis and distant metastasis in patient level in patients with recurrent pancreatic cancer
时间窗: 2 years
1) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph node metastasis in patient level in patients with primary pancreatic cancer
时间窗: 2 years
2) To assess the sensitivity and specificity 18F-FAPI-74 PET/CT in detection of distant metastasis in patient level in patients with primary pancreatic cancer
时间窗: 2 years
次要结局
未报告次要终点