NCT05508126

Brief Summary

Accurate preoperative staging of gastric cancer is of major importance for guiding therapeutic decision-making, preventing both under- and over-treatment. The purpose of this study is to investigate the diagnostic performance of the Multi-parametric magnetic resonance imaging (mpMRI) and dual-energy computed tomography (DECT) in gastric cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress87%
Nov 2021Dec 2026

Study Start

First participant enrolled

November 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3.6 years

First QC Date

August 11, 2022

Last Update Submit

October 10, 2024

Conditions

Gastric Cancer Stage

Keywords

Computed TomographyMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

  • Diagnostic performance of DECT and mpMRI in tumor staging assessment

    Accuracy for both imaging techniques in the prediction of tumor staging.

    2 years

  • Diagnostic performance of DECT and mpMRI in tumor restaging assessment

    Accuracy for both imaging techniques in the prediction of tumor restaging.

    2 years

Secondary Outcomes (7)

  • The kappa value

    2 years

  • Predictive value of DECT and mpMRI after the neoadjuvant treatment for pathologic response

    4 years

  • Disease free survival (DFS)

    4 years

  • Overall survival (OS)

    5 years

  • Likert scales 1-5

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Primary staging group I

All patients will be treated according to standard practice. Patients in group I are patients that will be stratified for radical gastrectomy or endoscopic resection. Group I will undergo only a primary staging. All patients will take DECT and mpMRI examination within 1 week before surgery.

Diagnostic Test: DECT examinationDiagnostic Test: mpMRI examination

Restaging group II

Patients in group II are patients that will be stratified for neoadjuvant chemotherapy. Group II will undergo a primary staging (DECT and mpMRI) and 1-2 times restaging (DECT and mpMRI).

Diagnostic Test: DECT examinationDiagnostic Test: mpMRI examination

Interventions

DECT examinationDIAGNOSTIC_TEST

DECT examinations will be performed using a 192-slice CT scanner (SOMATOM, Force, Siemens, Forchheim, Germany).

Primary staging group IRestaging group II
mpMRI examinationDIAGNOSTIC_TEST

The examinations were conducted on a 3-T MR scanner (MAGNETOM Skyra; Siemens Healthcare, Erlangen, Germany).

Primary staging group IRestaging group II

Eligibility Criteria

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

All patients diagnosed with gastric cancer by endoscopically biopsy will be considered for inclusion in the study.

You may qualify if:

  • Consecutive patients with preoperative pathologically confirmed GC by endoscopy and preoperative imaging data (DECT/mpMRI) were included.
  • No contraindications for CT/MRI examination
  • Written informed consent

You may not qualify if:

  • Patients with a history of previous therapy.
  • Patients with recurrent gastric cancer
  • Patients with a history of severe allergy to contrast agents
  • Patients with imaging artefacts affect the evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yu-Dong Zhang

Nanjing, 210029, China

RECRUITING

Related Publications (3)

  • Zhen Y, Xie Q, Liu L. Diagnostic Value of Spiral CT and Magnetic Resonance Imaging Scanning in Gastric Cancer and Precancerous Lesions. Scanning. 2022 May 23;2022:3627385. doi: 10.1155/2022/3627385. eCollection 2022.

    PMID: 35795615BACKGROUND

  • Giganti F, Orsenigo E, Arcidiacono PG, Nicoletti R, Albarello L, Ambrosi A, Salerno A, Esposito A, Petrone MC, Chiari D, Staudacher C, Del Maschio A, De Cobelli F. Preoperative locoregional staging of gastric cancer: is there a place for magnetic resonance imaging? Prospective comparison with EUS and multidetector computed tomography. Gastric Cancer. 2016 Jan;19(1):216-25. doi: 10.1007/s10120-015-0468-1. Epub 2015 Jan 23.

    PMID: 25614468BACKGROUND

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 19, 2022

Study Start

November 1, 2021

Primary Completion

June 1, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)