Study on the Value of Three DWI Scanning Sequences in Staging of Gastric Cancer

Comparative Study on the Value of Three DWI Scan Sequences of 3.0T Magnetic Resonance in Staging of Gastric Cancer

Accurate staging is critical for effective gastric cancer treatment planning. Conventional DWI (C-DWI) has limitations in image quality due to magnetic field inhomogeneity, which hampers precise T staging.

This study aims to compare the image quality and T staging accuracy of C-DWI, TSE-DWI, and ZOOMit-DWI (Z-DWI) sequences in MRI examinations of gastric cancer patients.

A prospective study plan to enroll 72 gastric cancer patients undergoing preoperative MRI with C-DWI, TSE-DWI, and Z-DWI sequences using a 3.0 T scanner. Quantitative metrics (ADC, SNR, CNR) and image quality were evaluated. T staging accuracy was assessed by comparing MRI results with postoperative pathological staging using ROC analysis.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Diagnostic test: Scanning parameter

• Study Type: Interventional
• Enrollment (Estimated): 129
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Yanli, master; Phone Number: 18987958050; Email: lyl2241@163.com
• Study Contact Backup: Name: Li Zhenhui, MD; Phone Number: 13698736132; Email: lizhenhui@kmmu.edu.cn

Study Locations

• China
  • Kunming, China
    • Recruiting
    • Yunnan Cancer Hospital
    • Contact: Zhang Guojun, Professor; Phone Number: 0871-68173640

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. The patient was diagnosed with gastric cancer by pathological biopsy
2. No biopsy was taken within 1 week before MR Examination to rule out the effect of bleeding on the image
3. No contraindications for MRI examination; And exclude serious heart, liver, kidney, cerebrovascular diseases.

Exclusion Criteria:

1. The image quality cannot meet the diagnostic criteria;
2. Patients could not tolerate MRI examination, resulting in incomplete MR-related sequence image data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: SS-EPI-DWI T-stage of gastric cancer
Other: TSE-DWI T-stage of gastric cancer	Diagnostic test: Scanning parameter; Based on abdominal scanning, TSE-DWI,ZOOMIT DWI and EPI-DWI scans were performed, and the study was divided into two steps according to the nanomotion criteria. The first step was self-controlled, which was divided into experimental group and control group. The experimental group included TSE-DWI,ZOOMit DWI, and the control group included EPI-DWI. Then the image quality was evaluated by subjective and objective evaluation indexes. In the second step, the three DWI stages were performed separately by four diagnosticians, with an interval of 1 month, and statistical analysis was performed at the end.
Other: ZOOM-DWI T-stage of gastric cancer	Diagnostic test: Scanning parameter; Based on abdominal scanning, TSE-DWI,ZOOMIT DWI and EPI-DWI scans were performed, and the study was divided into two steps according to the nanomotion criteria. The first step was self-controlled, which was divided into experimental group and control group. The experimental group included TSE-DWI,ZOOMit DWI, and the control group included EPI-DWI. Then the image quality was evaluated by subjective and objective evaluation indexes. In the second step, the three DWI stages were performed separately by four diagnosticians, with an interval of 1 month, and statistical analysis was performed at the end.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T staging of gastric cancer	Study on the value of three DWI scanning sequences in T staging of gastric cancer	one year

Collaborators and Investigators

• Sponsor: Yunnan Cancer Hospital
• Investigators: Study Director: Lianhua Ye, Ethics Committee of Yunnan Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: KYLX2023-167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No