跳至主要内容
临床试验/NCT05884463
NCT05884463已完成不适用

18F-FAPI PET/CT and 18F-FDG PET/CT in Patients With Pancreatic Adenocarcinoma : A Prospective, Single-Center, Comparative Study

Zhejiang University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Diagnostic value

研究概览

简要总结

To explore the potential efficacy of 18F-FAPI-04 PET/CT for PDAC tumour staging and compare the results with those obtained using 18F-FDG PET/CT.

详细描述

Accurate diagnosis and staging are crucial for selecting treatment for patients with pancreatic ductal adenocarcinoma (PDAC). The desmoplastic responses associated with PDAC are often characterised by hypometabolism. Here we investigated 18F-fibroblast activation protein inhibitor (18F-FAPI-04) positron emission tomography/computed tomography (PET/CT) in evaluation of PDAC, and compared the findings with those obtained using (18F)-fluorodeoxyglucose (18F-FDG).

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 who were suspected to have PDAC by radiological imaging patients who underwent paired 18F-FAPI-04 PET/CT and 18F-FDG PET/CT for metastasis screening, recurrence confirmation, or tumour staging patients who were willing to participate in clinical trials and signed an informed consent form.

排除标准

  • patients with a history of severe contrast allergy pregnant patients patients who were not pathologically diagnosed as showing PDAC.

研究组 & 干预措施

Experimental

Experimental

Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan

干预措施: 18F-FAPI (Drug)

Experimental

Experimental

Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan

干预措施: 18F-FDG (Drug)

结局指标

主要结局

Diagnostic value

时间窗: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

Sensitivity and Specificity of 18F-FAPI PET/CT for diagnosis and staging in comparison with 18F-FDG PET/CT

Maximum standardized uptake value

时间窗: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

SUVmax of 18F-FAPI PET/CT for lesions in comparison with 18F-FDG PET/CT

次要结局

  • Diagnostic efficacy for primary lesions(1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT))
  • SUVmax for lymph node(1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT))
  • SUVmax for distant metastasis(1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT))
  • Correlation between the SUVmax of 18F-FAPI and 18F-FDG uptake in patients with different treatment response(at least 2 months after treatment)
  • SUVmax for primary lesions(1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT))

研究者

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

TingBo Liang

Professor

Zhejiang University

研究点 (1)

Loading locations...

相似试验

相关资讯