Gastric Cancer StageNCT03015298
Comparing the Diagnostic Role of PET/MRI and of PET/CT Among Patients With Gastric Cancer
An observational study of Gastric Cancer Stage, run by Chinese PLA General Hospital.
Trial summary
The results of PET/MRI and PET/CT in each recruited gastric cancer patients will be compared. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer Stage
- What is being tested?
- PET/MRI and PET/CT
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort will recruit from patients diagnosed as gastric cancer and treated in the Department of general surgery.
Who may be able to join
- 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.
Who cannot join
- With other neoplastic disease.
- Suffering acute inflammatory disease
- History of chemo-radiotherapy
- Suffering prostate hyperplasia,glaucoma
Trial locations and contacts
No sites are listed yet.
About this study
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
The results of PET/MRI and PET/CT in each recruited gastric cancer patients will be compared.
Read the 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).
- Conditions
- Gastric Cancer Stage
- Being tested
- PET/MRI, PET/CT
- Keywords
- gastric cancer, Simultaneous PET/MRI, PET/CT
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIDevice
Also called Positron emission tomography-magnetic resonance imaging
The recruited patients will receive a PET/MRI examination to evaluation the stage and resectability of the cancer.
PET/CTDevice
Also called Positron emission tomography-computed tomography
At the next day of PET/MRI examination,A PET/CT examination will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PET/MRI; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days
Secondary outcomes (7)
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.
Measured: 5 days
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.
Measured: 3 days
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.
Measured: 3 days
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.
Measured: 3 days
The expression level of Receptor tyrosine-protein kinase erbB-2(HER2)
Acquire from pathology results
Measured: 5 days
The expression level of Receptors for vascular endothelial growth factor(VEGFR)
Acquire from pathology results
Measured: 5 days
Follow-up data
results of conventional imaging examination and tumor biomarkers examination.
Measured: at lest 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer StageStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chen, Chinese PLA General Hospital
- Investigators
- Jianxin Cui, Doctor, Study director, the Chinese PLA General HospitalYi Liu, Principal investigator, the Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015298
- Sponsor's protocol ID
- Experiment20160901
- Status last verified
- Jan 2017
- First submitted
- 29 Dec 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03015298
- Acronym / sponsor ID
- Experiment20160901
- Conditions
- Gastric Cancer Stage
- Keywords
- gastric cancer, Simultaneous PET/MRI, PET/CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The results of PET/MRI and PET/CT in each recruited gastric cancer patients will be compared.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer | – | Device: PET/MRI, Device: PET/CTEach patient will perform a PET/MRI examination,and in the next day,a PET/CT.All the examinations are performed before the operation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will recruit from patients diagnosed as gastric cancer and treated in the Department of general surgery.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- With other neoplastic disease.
- Suffering acute inflammatory disease
- History of chemo-radiotherapy
- Suffering prostate hyperplasia,glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MRIAlso: Positron emission tomography-magnetic resonance imagingThe recruited patients will receive a PET/MRI examination to evaluation the stage and resectability of the cancer. | Device | Gastric cancer |
| PET/CTAlso: Positron emission tomography-computed tomographyAt the next day of PET/MRI examination,A PET/CT examination will be performed. | Device | Gastric cancer |
Primary outcome
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
7 secondary outcomes
Histopathological diagnosis
Time frame: 5 days
Results of CT/Endoscopic ultrasound(EUS) image
Time frame: 3 days
Numerical values of Standard uptake value(SUV)
Time frame: 3 days
Apparent Diffusion Coefficient(ADC)
Time frame: 3 days
The expression level of Receptor tyrosine-protein kinase erbB-2(HER2)
Time frame: 5 days
The expression level of Receptors for vascular endothelial growth factor(VEGFR)
Time frame: 5 days
Follow-up data
Time frame: at lest 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianxin Cui, Doctor study director
the Chinese PLA General Hospital
Yi Liu principal investigator
the Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer Stage, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Chen, Master (86-13801290395, chenlinbj@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The results of the PET/MRI and PET/CT examination (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.