Clinical trial NCT04028375: Study of CT and MR in the Gastric Cancer
Official title: Clinical Study of CT and MR in Staging and Prediction of Response in Patients With Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer Stage
CT
MRI
Neoadjuvant Therapy
Keywords: Gastric Cancer
MRI
MSCT
Staging
Prediction and Prognosis
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2019-07-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with endoscopically biopsy-proven gastric cancer will receive treatment

Brief summary: It is very significant that assessing staging in gastric cancer patients before surgery, furthermore, determining the optimize surgical strategy ,predict the the efficacy of neoadjuvant therapy for patients. For patients who are ineffective in neoadjuvant therapy, surgery will be more meaningful.

It has been reported that the application of CT(computed tomography,CT) and MR(magnetic resonance,MR) in staging of gastric cancer, but not in predicting clinical response to neoadjuvant therapy for gastric cancer. Only a few studies focused on T staging using conventional MRI in gastric cancer, however , relatively new sequences in the chest deserve widely used. To develop a pre-treatment evaluation methods for TN staging in patient with gastric cancer by utilization of the new imaging methods (T2-TSE-BLADE,T2 maps, StarVIBE, iShim-DWI and high resolution CT). By analysing the relationship between TN staging and imaging features to find the imaging characteristics for TN staging, and to find the indicators of new technology and reference values for facilitate pre-treatment diagnosis of TN staging, optimize surgical strategy , predict the the efficacy of adjunctive therapy , and OS and define the range of lymph node for radiotherapy , as making personal treatment planning for gastric cancer .

Detailed description: To explore the value of CT and MR using multiple sequences, including T2-TSE-BLADE, T2 maps StarVIBE, and iShim-DWI in evaluating the preoperative TN staging and prediction of response to neoadjuvant therapy and OS in patients with gastric cancer.

Patients with endoscopically biopsy-proven gastric cancer were prospectively enrolled for imaging on CT and a 3T MRI scanner . The MRI protocol included T2-TSE-BLADE, T2 maps,iShim-DWI(diffusion weighted imaging,DWI)and StarVIBE sequences, and so on. Patients received treatment according to NCCN guideline(the National Comprehensive Cancer Network,NCCN). Readers assigned a TN stage on CT and MRI, and post-operative pathologic confirmation was considered the gold standard.

Inter-reader agreement, the diagnostic accuracy of TN staging on CT and MRI were analyzed and compared to post-operative pathologic TN staging separately. MRI features were analyzed to find the correlation between pretreatment MRI features and response or OS. The study will include 400 patients. Inter-reader agreements of TN staging were analyzed excellent for CT and MRI. Diagnostic accuracy of CT and MRI will be calculated separately.

Eligibility criteria: Inclusion Criteria:

1. Consecutive patients with preoperative pathologically con-firmed gastric cancer by endoscopy and preoperative imaging data (esophagography\\CT\\EUS\\MRI) were included.
2. No contraindications for MRI examination. No contraindications contrast.
3. The patients participate in this study with informed consent.

Exclusion Criteria:

1. The patients couldn't performed MSCT or MR scanning or artefacts affect the evaluation.
2. The patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy .
3. PatientsThe patients refuse to participate in the project.
4. Other situations considered by investigators not meet the inclusion criteria.

Primary outcomes:
measure: MSCT and MRI staging in Gastric Cancer.
timeFrame: up to 2 year
Secondary outcomes:
measure: MSCT and MRI prediction of prognosis in gastric cancer
timeFrame: up to 2 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References:
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