A Prospective Pilot Study to Explore Performance and Efficacy of 68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The numbers of patients who been changed the treatment methods
研究概览
简要总结
Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitutes a major proportion of cells within the tumor microenvironment, especially in primary pancreatic ductal carcinoma (PDAC). In this prospective study, we aimed to evaluate the performance and value of 68Ga-FAPI-04 PET/CT in the patients with PDAC.
详细描述
With an incidence rate of 10 cases per 100,000 people per year, cancer of the pancreas is the third most common malignancy of the gastrointestinal tract. The overall survival for patients with pancreatic cancer is very poor, with a 5-year survival of 1% to 4%. Successful therapy depends on early diagnosis. The discrimination between benign and malignancies of the pancreas and the assessment of local resectability and distant metastases of the pancreatic cancer remains challenging with different imaging modalities such as ultrasound (US), endoscopic US (EUS), multidetector row computed tomography (MDCT), magnetic resonance imaging (MRI), and 18F-FDG positron emission tomography (PET). PDAC is characterized by a distinct and exuberant desmoplastic stroma, with stromal components outnumbering the pancreatic cancer cells. In PDAC, more than 90% of the tumour volume consists of cancer-associated fibroblasts (CAF). Fibroblast activation protein (FAP) is highly and selectively expressed in CAFs but is weakly expressed or not detected in normal tissues. The aim of this study was to evaluate the impact of FAPI-PET/CT on the clinical management of patients with suspected pancreatic cancer.
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 pancreatic lesions
- •Signed written consent.
排除标准
- •breastfeeding;
- •any medical condition that in the opinion of the investigator may significantly interfere with study compliance
研究组 & 干预措施
68Ga-FAPI PET/CT examination
Patients with suspected pancreatic lesions underwent 68Ga-FAPI PET/CT to distinguish benign and malignant lesions, to evaluate the resectability of lesions and to detect distant metastasis. The clinicians decided the treatment methods based on the results of 68Ga-FAPI PET/CT.
干预措施: 68Ga-FAPI Positron Emission Tomography-Computed Tomography (Diagnostic Test)
结局指标
主要结局
The numbers of patients who been changed the treatment methods
时间窗: through study completion, an average of 0.5 year
Determination the patients numbers who been changed the treatment methods after 68Ga-FAPI PET
Progression Free Survival (PFS)
时间窗: through study completion, an average of 1 year
Determination the progression free survival of included patients
The numbers of lesions
时间窗: through study completion, an average of 0.5 year
Determination the lesions numbers were detected by 68Ga-FAPI
Standard Uptake Value (SUV）
时间窗: through study completion, an average of 0.5 year
Determined and compared the SUV for detected lesions in 68Ga-FAPI
Overall Survival (OS)
时间窗: through study completion, an average of 2 year
Determination the overall survival of included patients
次要结局
未报告次要终点