<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03015298</url>
  </required_header>
  <id_info>
    <org_study_id>Experiment20160901</org_study_id>
    <nct_id>NCT03015298</nct_id>
  </id_info>
  <brief_title>Comparing the Diagnostic Role of PET/MRI and of PET/CT Among Patients With Gastric Cancer</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The results of PET/MRI and PET/CT in each recruited gastric cancer patients will be compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective comparison of PET/MRI and PET/CT for gastric cancer will be performed,to&#xD;
      evaluate the value of PET/MRI in predicting the preoperative staging and resectability of&#xD;
      gastric cancer and investigate the role of PET/MRI in gastric cancer diagnosis.The evaluation&#xD;
      parameters are the diagnostic accuracy of gastric cancer staging( including the overall&#xD;
      accuracy, sensitivity, and specificity) and the receiver operating characteristic (ROC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The results of the PET/MRI and PET/CT examination</measure>
    <time_frame>3 days</time_frame>
    <description>Two experienced radiologists independently assess the TNM staging of gastric cancer using preoperative PET/MRI and PET/CT images</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histopathological diagnosis</measure>
    <time_frame>5 days</time_frame>
    <description>including definitely T stage in Tx, number of regional lymph node metastasis,result of histologic subtypes of carcinoma,result of other cytological examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Results of CT/Endoscopic ultrasound(EUS) image</measure>
    <time_frame>3 days</time_frame>
    <description>Experienced radiologists assess definitely T stage in Tx, number of regional lymph node metastasis,with or without distant metastasis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical values of Standard uptake value(SUV)</measure>
    <time_frame>3 days</time_frame>
    <description>Standard uptake value(SUV) is defined as the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Diffusion Coefficient(ADC)</measure>
    <time_frame>3 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The expression level of Receptor tyrosine-protein kinase erbB-2(HER2)</measure>
    <time_frame>5 days</time_frame>
    <description>Acquire from pathology results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The expression level of Receptors for vascular endothelial growth factor(VEGFR)</measure>
    <time_frame>5 days</time_frame>
    <description>Acquire from pathology results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up data</measure>
    <time_frame>at lest 6 months</time_frame>
    <description>results of conventional imaging examination and tumor biomarkers examination.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Gastric Cancer Stage</condition>
  <arm_group>
    <arm_group_label>Gastric cancer</arm_group_label>
    <description>Each patient will perform a PET/MRI examination,and in the next day,a PET/CT.All the examinations are performed before the operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PET/MRI</intervention_name>
    <description>The recruited patients will receive a PET/MRI examination to evaluation the stage and resectability of the cancer.</description>
    <arm_group_label>Gastric cancer</arm_group_label>
    <other_name>Positron emission tomography-magnetic resonance imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PET/CT</intervention_name>
    <description>At the next day of PET/MRI examination,A PET/CT examination will be performed.</description>
    <arm_group_label>Gastric cancer</arm_group_label>
    <other_name>Positron emission tomography-computed tomography</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The cohort will recruit from patients diagnosed as gastric cancer and treated in the&#xD;
        Department of general surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histological diagnosis of gastric cancer&#xD;
&#xD;
          2. No previous treatment history for gastric cancer&#xD;
&#xD;
          3. Without complications of obstruction,bleeding and so on&#xD;
&#xD;
          4. Without severe diabetes,the levels of blood glucose &lt;6.2 mmol/L .&#xD;
&#xD;
          5. No cardiac pacemarker,never stimulator or other metal substitute materials in vivo.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. With other neoplastic disease.&#xD;
&#xD;
          2. Suffering acute inflammatory disease&#xD;
&#xD;
          3. History of chemo-radiotherapy&#xD;
&#xD;
          4. Suffering prostate hyperplasia,glaucoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianxin Cui, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>the Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yi Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>the Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lin Chen, Master</last_name>
    <phone>86-13801290395</phone>
    <email>chenlinbj@sina.com</email>
  </overall_contact>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Lin Chen</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>gastric cancer</keyword>
  <keyword>Simultaneous PET/MRI</keyword>
  <keyword>PET/CT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015298
org study id: Experiment20160901
nct id: NCT03015298
lead sponsor: 
has dmc: Yes
The results of PET/MRI and PET/CT in each recruited gastric cancer patients will be compared.
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).
observational model: Cohort
time perspective: Prospective
measure: The results of the PET/MRI and PET/CT examination
time frame: 3 days
description: Two experienced radiologists independently assess the TNM staging of gastric cancer using preoperative PET/MRI and PET/CT images
measure: Histopathological diagnosis
time frame: 5 days
description: including definitely T stage in Tx, number of regional lymph node metastasis,result of histologic subtypes of carcinoma,result of other cytological examination.
measure: Results of CT/Endoscopic ultrasound(EUS) image
time frame: 3 days
description: Experienced radiologists assess definitely T stage in Tx, number of regional lymph node metastasis,with or without distant metastasis.
measure: Numerical values of Standard uptake value(SUV)
time frame: 3 days
description: Standard uptake value(SUV) is defined as the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity.
measure: Apparent Diffusion Coefficient(ADC)
time frame: 3 days
description: 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.
measure: The expression level of Receptor tyrosine-protein kinase erbB-2(HER2)
time frame: 5 days
description: Acquire from pathology results
measure: The expression level of Receptors for vascular endothelial growth factor(VEGFR)
time frame: 5 days
description: Acquire from pathology results
measure: Follow-up data
time frame: at lest 6 months
description: results of conventional imaging examination and tumor biomarkers examination.
arm group label: Gastric cancer
description: Each patient will perform a PET/MRI examination,and in the next day,a PET/CT.All the examinations are performed before the operation.
intervention type: Device
intervention name: PET/MRI
description: The recruited patients will receive a PET/MRI examination to evaluation the stage and resectability of the cancer.
arm group label: Gastric cancer
other name: Positron emission tomography-magnetic resonance imaging
intervention type: Device
intervention name: PET/CT
description: At the next day of PET/MRI examination,A PET/CT examination will be performed.
arm group label: Gastric cancer
other name: Positron emission tomography-computed tomography
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jianxin Cui, Doctor
role: Study Director
affiliation: the Chinese PLA General Hospital
last name: Yi Liu
role: Principal Investigator
affiliation: the Chinese PLA General Hospital
last name: Lin Chen, Master
phone: 86-13801290395
email: chenlinbj@sina.com
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Lin Chen
investigator title: Director
mesh term: Stomach Neoplasms
sharing ipd: No