Study of CT and MR in the Gastric Cancer

NCT ID: NCT04028375

Last Updated: 2020-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Gastric Cancer Stage CT MRI Neoadjuvant Therapy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Henan Cancer Hospital

Zhengzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jinrong Qu

Role: CONTACT

0371-65587595

Jing Ding, Master

Role: CONTACT

0371-65587251

Facility Contacts

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Baoxia He, MD

Role: primary

8637165588007

References

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Giganti F, Tang L, Baba H. Gastric cancer and imaging biomarkers: Part 1 - a critical review of DW-MRI and CE-MDCT findings. Eur Radiol. 2019 Apr;29(4):1743-1753. doi: 10.1007/s00330-018-5732-4. Epub 2018 Oct 2.

Reference Type BACKGROUND
PMID: 30280246 (View on PubMed)

Pang L, Wang J, Fan Y, Xu R, Bai Y, Bai L. Correlations of TNM staging and lymph node metastasis of gastric cancer with MRI features and VEGF expression. Cancer Biomark. 2018;23(1):53-59. doi: 10.3233/CBM-181287.

Reference Type BACKGROUND
PMID: 30010108 (View on PubMed)

Borggreve AS, Goense L, Brenkman HJF, Mook S, Meijer GJ, Wessels FJ, Verheij M, Jansen EPM, van Hillegersberg R, van Rossum PSN, Ruurda JP. Imaging strategies in the management of gastric cancer: current role and future potential of MRI. Br J Radiol. 2019 May;92(1097):20181044. doi: 10.1259/bjr.20181044. Epub 2019 Mar 5.

Reference Type BACKGROUND
PMID: 30789792 (View on PubMed)

Zhou J, Shen J, Seifer BJ, Jiang S, Wang J, Xiong H, Xie L, Wang L, Sui X. Approaches and genetic determinants in predicting response to neoadjuvant chemotherapy in locally advanced gastric cancer. Oncotarget. 2017 May 2;8(18):30477-30494. doi: 10.18632/oncotarget.12955.

Reference Type BACKGROUND
PMID: 27802185 (View on PubMed)

Kwee RM, Kwee TC. Role of imaging in predicting response to neoadjuvant chemotherapy in gastric cancer. World J Gastroenterol. 2014 Feb 21;20(7):1650-6. doi: 10.3748/wjg.v20.i7.1650.

Reference Type BACKGROUND
PMID: 24587644 (View on PubMed)

Ng J, Lee P. The Role of Radiotherapy in Localized Esophageal and Gastric Cancer. Hematol Oncol Clin North Am. 2017 Jun;31(3):453-468. doi: 10.1016/j.hoc.2017.01.005. Epub 2017 Mar 22.

Reference Type BACKGROUND
PMID: 28501087 (View on PubMed)

Al-Batran SE, Homann N, Pauligk C, Illerhaus G, Martens UM, Stoehlmacher J, Schmalenberg H, Luley KB, Prasnikar N, Egger M, Probst S, Messmann H, Moehler M, Fischbach W, Hartmann JT, Mayer F, Hoffkes HG, Koenigsmann M, Arnold D, Kraus TW, Grimm K, Berkhoff S, Post S, Jager E, Bechstein W, Ronellenfitsch U, Monig S, Hofheinz RD. Effect of Neoadjuvant Chemotherapy Followed by Surgical Resection on Survival in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Cancer: The AIO-FLOT3 Trial. JAMA Oncol. 2017 Sep 1;3(9):1237-1244. doi: 10.1001/jamaoncol.2017.0515.

Reference Type BACKGROUND
PMID: 28448662 (View on PubMed)

Li J, Yan LL, Zhang HK, Wang Y, Xu SN, Chen XJ, Qu JR. Application of intravoxel incoherent motion diffusion-weighted imaging for preoperative knowledge of lymphovascular invasion in gastric cancer: a prospective study. Abdom Radiol (NY). 2023 Jul;48(7):2207-2218. doi: 10.1007/s00261-023-03920-2. Epub 2023 Apr 21.

Reference Type DERIVED
PMID: 37085731 (View on PubMed)

Other Identifiers

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FSK002

Identifier Type: -

Identifier Source: org_study_id

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