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

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03015298
Collaborator
(none)
100
17

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: PET/MRI
  • Device: PET/CT

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. The expression level of Receptor tyrosine-protein kinase erbB-2(HER2) [5 days]

      Acquire from pathology results

    6. The expression level of Receptors for vascular endothelial growth factor(VEGFR) [5 days]

      Acquire from pathology results

    7. Follow-up data [at lest 6 months]

      results of conventional imaging examination and tumor biomarkers examination.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lin Chen, Director, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT03015298
    Other Study ID Numbers:
    • Experiment20160901
    First Posted:
    Jan 10, 2017
    Last Update Posted:
    Jan 10, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Lin Chen, Director, Chinese PLA General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 10, 2017