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

Gastric Cancer Stage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03015298
• Other study ID #: Experiment20160901
• Status: Not yet recruiting
• Phase: N/A
• First received: December 29, 2016
• Last updated: January 9, 2017
• Start date: January 2017
• Est. completion date: June 2018

Study information

• Verified date: January 2017
• Source: Chinese PLA General Hospital
• Contact: Lin Chen, Master
• Phone: 86-13801290395
• Email: chenlinbj[@]sina.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer Stage
• Stomach Neoplasms

Intervention

Device:
• PET/MRI
The recruited patients will receive a PET/MRI examination to evaluation the stage and resectability of the cancer.
• PET/CT
At the next day of PET/MRI examination,A PET/CT examination will be performed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	The expression level of Receptor tyrosine-protein kinase erbB-2(HER2)	Acquire from pathology results	5 days	No
Secondary	The expression level of Receptors for vascular endothelial growth factor(VEGFR)	Acquire from pathology results	5 days	No
Secondary	Follow-up data	results of conventional imaging examination and tumor biomarkers examination.	at lest 6 months	No