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

January 9, 2017 updated by: Lin Chen, Chinese PLA General Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The cohort will recruit from patients diagnosed as gastric cancer and treated in the Department of general surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastric cancer
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
The recruited patients will receive a PET/MRI examination to evaluation the stage and resectability of the cancer.
Other Names:
  • Positron emission tomography-magnetic resonance imaging
Device: PET/CT
At the next day of PET/MRI examination,A PET/CT examination will be performed.
Other Names:
  • Positron emission tomography-computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histopathological diagnosis
Time Frame: 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.
5 days
Results of CT/Endoscopic ultrasound(EUS) image
Time Frame: 3 days
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)
Time Frame: 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.
3 days
Apparent Diffusion Coefficient(ADC)
Time Frame: 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.
3 days
The expression level of Receptor tyrosine-protein kinase erbB-2(HER2)
Time Frame: 5 days
Acquire from pathology results
5 days
The expression level of Receptors for vascular endothelial growth factor(VEGFR)
Time Frame: 5 days
Acquire from pathology results
5 days
Follow-up data
Time Frame: at lest 6 months
results of conventional imaging examination and tumor biomarkers examination.
at lest 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Study Director: Jianxin Cui, Doctor, The Chinese PLA General Hospital
  • Principal Investigator: Yi Liu, The Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

December 29, 2016

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Experiment20160901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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