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

• Conditions: Gastric Cancer Stage
• Interventions: Device: PET/MRI; Device: PET/CT

• Registration Number: NCT03015298
• Lead Sponsor: Chinese PLA General Hospital

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).

Study Timeline

• Study First Submitted: 2016-12-29
• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted QC: 2017-01-09
• Last Update Submitted: 2017-01-09
• Study First Posted: 2017-01-10
• Last Update Posted: 2017-01-10
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

1. With other neoplastic disease.
2. Suffering acute inflammatory disease
3. History of chemo-radiotherapy
4. Suffering prostate hyperplasia,glaucoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastric cancer	PET/CT	Each patient will perform a PET/MRI examination,and in the next day,a PET/CT.All the examinations are performed before the operation.
Gastric cancer	PET/MRI	Each patient will perform a PET/MRI examination,and in the next day,a PET/CT.All the examinations are performed before the operation.

Primary Outcome Measures

Name	Time	Method
The results of the PET/MRI and PET/CT examination	3 days	Two experienced radiologists independently assess the TNM staging of gastric cancer using preoperative PET/MRI and PET/CT images

Secondary Outcome Measures

Name	Time	Method
Apparent Diffusion Coefficient(ADC)	3 days	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.
The expression level of Receptor tyrosine-protein kinase erbB-2(HER2)	5 days	Acquire from pathology results
Histopathological diagnosis	5 days	including definitely T stage in Tx, number of regional lymph node metastasis,result of histologic subtypes of carcinoma,result of other cytological examination.
Results of CT/Endoscopic ultrasound(EUS) image	3 days	Experienced radiologists assess definitely T stage in Tx, number of regional lymph node metastasis,with or without distant metastasis.
Follow-up data	at lest 6 months	results of conventional imaging examination and tumor biomarkers examination.
Numerical values of Standard uptake value(SUV)	3 days	Standard uptake value(SUV) is defined as the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity.
The expression level of Receptors for vascular endothelial growth factor(VEGFR)	5 days	Acquire from pathology results