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临床试验/NCT05275985
NCT05275985Unknown不适用

A Prospective Pilot Study to Explore Performance and Efficacy of 68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma Patients

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Overall Survival (OS)

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

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

结局指标

主要结局

Overall Survival (OS)

时间窗: through study completion, an average of 2 year

Determination the overall 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

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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