NCT03015298

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

December 29, 2016

Last Update Submit

January 9, 2017

Conditions

Keywords

gastric cancerSimultaneous PET/MRIPET/CT

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Histopathological diagnosis

    5 days

  • Results of CT/Endoscopic ultrasound(EUS) image

    3 days

  • Numerical values of Standard uptake value(SUV)

    3 days

  • Apparent Diffusion Coefficient(ADC)

    3 days

  • The expression level of Receptor tyrosine-protein kinase erbB-2(HER2)

    5 days

  • +2 more secondary outcomes

Study Arms (1)

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/MRIDevice: PET/CT

Interventions

PET/MRIDEVICE

The recruited patients will receive a PET/MRI examination to evaluation the stage and resectability of the cancer.

Also known as: Positron emission tomography-magnetic resonance imaging
Gastric cancer
PET/CTDEVICE

At the next day of PET/MRI examination,A PET/CT examination will be performed.

Also known as: Positron emission tomography-computed tomography
Gastric cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • With other neoplastic disease.
  • Suffering acute inflammatory disease
  • History of chemo-radiotherapy
  • Suffering prostate hyperplasia,glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Jianxin Cui, Doctor

    the Chinese PLA General Hospital

    STUDY DIRECTOR
  • Yi Liu

    the Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Chen, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 29, 2016

First Posted

January 10, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

January 10, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share