NCT04028375

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 .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

July 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 1, 2020

Status Verified

July 1, 2019

Enrollment Period

4.3 years

First QC Date

July 17, 2019

Last Update Submit

March 31, 2020

Conditions

Gastric Cancer StageCTMRINeoadjuvant Therapy

Keywords

Gastric CancerMRIMSCTStagingPrediction and Prognosis

Outcome Measures

Primary Outcomes (1)

  • MSCT and MRI staging in Gastric Cancer.

    To evaluate the staging of gastric cancer treated with systematic therapy through MSCT and 3 T MRI which using multiple sequences.

    up to 2 year

Secondary Outcomes (1)

  • MSCT and MRI prediction of prognosis in gastric cancer

    up to 2 year

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with endoscopically biopsy-proven gastric cancer will receive treatment

You may qualify if:

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

You may not qualify if:

  • The patients couldn't performed MSCT or MR scanning or artefacts affect the evaluation.
  • The patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy .
  • PatientsThe patients refuse to participate in the project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 30280246BACKGROUND

  • 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.

    PMID: 30010108BACKGROUND

  • 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.

    PMID: 30789792BACKGROUND

  • 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.

    PMID: 27802185BACKGROUND

  • 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.

    PMID: 24587644BACKGROUND

  • 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.

    PMID: 28501087BACKGROUND

  • 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.

    PMID: 28448662BACKGROUND

  • 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.

    PMID: 37085731DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Jinrong Qu

CONTACT

0371-65587595qjryq@126.com

Jing Ding, Master

CONTACT

0371-65587251dingjing201305@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 22, 2019

Study Start

September 1, 2019

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 1, 2020

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)