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

NCT ID: NCT06735105

Last Updated: 2024-12-16

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-23

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SS-EPI-DWI T-stage of gastric cancer

Group Type NO_INTERVENTION

No interventions assigned to this group

TSE-DWI T-stage of gastric cancer

Group Type OTHER

Scanning parameter

Intervention Type DIAGNOSTIC_TEST

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.

ZOOM-DWI T-stage of gastric cancer

Group Type OTHER

Scanning parameter

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yunnan Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lianhua Ye

Role: STUDY_DIRECTOR

Ethics Committee of Yunnan Provincial Cancer Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yunnan Cancer Hospital

Kunming, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Li Yanli, master

Role: CONTACT

Phone: 18987958050

Email: [email protected]

Li Zhenhui, MD

Role: CONTACT

Phone: 13698736132

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhang Guojun, Professor

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KYLX2023-167

Identifier Type: -

Identifier Source: org_study_id