跳至主要内容
临床试验/NCT03015298
NCT03015298Unknown不适用

Comparing the Diagnostic Role of 18F-FDG PET/MRI and of 18F-FDG PET/CT Among Patients With Gastric Cancer:A Randomized Controlled Trial

Chinese PLA General Hospital0 个研究点目标入组 100 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
The results of the PET/MRI and PET/CT examination

研究概览

简要总结

The results of PET/MRI and PET/CT in each recruited gastric cancer patients will be compared.

详细描述

A prospective comparison of PET/MRI and PET/CT for gastric cancer will be performed,to evaluate the value of PET/MRI in predicting the preoperative staging and resectability of gastric cancer and investigate the role of PET/MRI in gastric cancer diagnosis.The evaluation parameters are the diagnostic accuracy of gastric cancer staging( including the overall accuracy, sensitivity, and specificity) and the receiver operating characteristic (ROC).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histological diagnosis of gastric cancer
  • No previous treatment history for gastric cancer
  • Without complications of obstruction,bleeding and so on
  • Without severe diabetes,the levels of blood glucose <6.2 mmol/L .
  • No cardiac pacemarker,never stimulator or other metal substitute materials in vivo.

排除标准

  • With other neoplastic disease.
  • Suffering acute inflammatory disease
  • History of chemo-radiotherapy
  • Suffering prostate hyperplasia,glaucoma

结局指标

主要结局

The results of the PET/MRI and PET/CT examination

时间窗: 3 days

Two experienced radiologists independently assess the TNM staging of gastric cancer using preoperative PET/MRI and PET/CT images

次要结局

  • Apparent Diffusion Coefficient(ADC)(3 days)
  • The expression level of Receptor tyrosine-protein kinase erbB-2(HER2)(5 days)
  • Histopathological diagnosis(5 days)
  • Results of CT/Endoscopic ultrasound(EUS) image(3 days)
  • Follow-up data(at lest 6 months)
  • Numerical values of Standard uptake value(SUV)(3 days)
  • The expression level of Receptors for vascular endothelial growth factor(VEGFR)(5 days)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lin Chen

Director

Chinese PLA General Hospital

相似试验

Comparing the Diagnostic Role of PET/MRI and of... | 临床试验