Comparing the Diagnostic Role of PET/MRI and of PET/CT Among Patients With Gastric Cancer

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

Detailed Description
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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).

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

Conditions
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Gastric Cancer Stage

Intervention / Treatment
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* Device: PET/MRI
* Device: PET/CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric cancer<br>Each patient will perform a PET/MRI examination,and in the next day,a PET/CT.All the examinations are performed before the operation. | Device: PET/MRI<br>* The recruited patients will receive a PET/MRI examination to evaluation the stage and resectability of the cancer.<br>* Other names: Positron emission tomography-magnetic resonance imaging;Device: PET/CT<br>* At the next day of PET/MRI examination,A PET/CT examination will be performed.<br>* Other names: Positron emission tomography-computed tomography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The results of the PET/MRI and PET/CT examination | Two experienced radiologists independently assess the TNM staging of gastric cancer using preoperative PET/MRI and PET/CT images | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histopathological diagnosis | including definitely T stage in Tx, number of regional lymph node metastasis,result of histologic subtypes of carcinoma,result of other cytological examination. | 5 days | 
| Results of CT/Endoscopic ultrasound(EUS) image | Experienced radiologists assess definitely T stage in Tx, number of regional lymph node metastasis,with or without distant metastasis. | 3 days | 
| Numerical values of Standard uptake value(SUV) | Standard uptake value(SUV) is defined as the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity. | 3 days | 
| Apparent Diffusion Coefficient(ADC) | Apparent Diffusion Coefficient(ADC) will be measured using a curved Placement of region of interest(ROI) to include the high signal and be read out on ADC maps by Diffusion-weighted magnetic resonance imaging (DWI or DW-MRI) analysis software. | 3 days | 
| The expression level of Receptor tyrosine-protein kinase erbB-2(HER2) | Acquire from pathology results | 5 days | 
| The expression level of Receptors for vascular endothelial growth factor(VEGFR) | Acquire from pathology results | 5 days | 
| Follow-up data | results of conventional imaging examination and tumor biomarkers examination. | at lest 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, gastric cancer, Simultaneous PET/MRI