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Study of CT and MR in the Gastric Cancer
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 .
| Condition or disease | Intervention/treatment |
|---|---|
| Gastric Cancer Stage CT MRI Neoadjuvant Therapy | Other: No intervention |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 400 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Clinical Study of CT and MR in Staging and Prediction of Response in Patients With Gastric Cancer |
| Actual Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | December 1, 2023 |
| Estimated Study Completion Date : | December 1, 2023 |
- MSCT and MRI staging in Gastric Cancer. [ Time Frame: up to 2 year ]To evaluate the staging of gastric cancer treated with systematic therapy through MSCT and 3 T MRI which using multiple sequences.
- MSCT and MRI prediction of prognosis in gastric cancer [ Time Frame: up to 2 year ]To construct a model,a depth convolution neural network based on MSCTand multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features and prognosis,could further help to improve the prediction of response and OS of gastric cancer treated with systematic therapy.
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 17, 2019 | ||||||||
| First Posted Date | July 22, 2019 | ||||||||
| Last Update Posted Date | April 1, 2020 | ||||||||
| Actual Study Start Date | September 1, 2019 | ||||||||
| Estimated Primary Completion Date | December 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
MSCT and MRI staging in Gastric Cancer. [ Time Frame: up to 2 year ] To evaluate the staging of gastric cancer treated with systematic therapy through MSCT and 3 T MRI which using multiple sequences.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
MSCT and MRI prediction of prognosis in gastric cancer [ Time Frame: up to 2 year ] To construct a model,a depth convolution neural network based on MSCTand multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features and prognosis,could further help to improve the prediction of response and OS of gastric cancer treated with systematic therapy.
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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 | ||||||||
| 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 . |
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| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Subjects with endoscopically biopsy-proven gastric cancer will receive treatment | ||||||||
| Condition |
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| Intervention | Other: No intervention
No intervention
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
400 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 1, 2023 | ||||||||
| Estimated Primary Completion Date | December 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04028375 | ||||||||
| Other Study ID Numbers | FSK002 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Henan Cancer Hospital | ||||||||
| Study Sponsor | Henan Cancer Hospital | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Henan Cancer Hospital | ||||||||
| Verification Date | July 2019 | ||||||||
