跳至主要内容
临床试验/NCT05806333
NCT05806333招募中不适用

Diagnostic Performance of [18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity

Jilin University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Diagnostic performance of FAPI PET

研究概览

简要总结

Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. We aim to conduct a prospective study to investigate the diagnostic perfoemance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.

详细描述

Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a promising approach for visualizing CAFs. CAFs are crucial components of the tumor stroma, promote the growth of cancer cells, and are associated with poor prognosis. Currently, 18F-labelled fbroblast activation protein inhibitor 18F-FAPI has shown promising diagnostic value in many types of tumors, especially those in which are not avid for 18F-FDF , and several studies have demonstrated that 18F-FAPI PET/CT is superior to 18F-FDG PET/CT for detecting liver cancer and has lower tracer uptake in normal liver tissue. We aim to conduct a prospective study to investigate the diagnostic performance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.

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 liver malignant lesions based on traditional diagnostic imaging (CT or MRI or ultrasound) and clinical symptoms;
  • patients underwent [18F]FDG PET/CT with negative findings (suspicious primary and/or metastatic lesions were hypo- or isometabolic on [18F]FDG PET/CT);
  • patients who agreed to undergo [18F]FAPI PET/CT scans within 1 week.

排除标准

  • pregnancy;
  • age<18 years old;
  • patients with chemo/radio/targeted therapy before scanning;
  • inability to provide informed consent (signed by participant, parent, or legal representative).

结局指标

主要结局

Diagnostic performance of FAPI PET

时间窗: 1 year

Sensitivity and specificity in detecting liver cancer

次要结局

未报告次要终点

研究者

发起方
Jilin University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji Bin

PHD

Jilin University

研究点 (1)

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