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Clinical Trials/NCT03015298
NCT03015298
Unknown
Not Applicable

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 sites100 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Cancer Stage
Sponsor
Chinese PLA General Hospital
Enrollment
100
Primary Endpoint
The results of the PET/MRI and PET/CT examination
Last Updated
9 years ago

Overview

Brief Summary

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

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
June 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chinese PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lin Chen

Director

Chinese PLA General Hospital

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 3 days

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

Secondary Outcomes

  • 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)

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