NCT06869694

Brief Summary

Accurate preoperative prediction of risk stratification, treatment response, and survival prognosis in gastric cancer is important for improving clinical treatment decisions, prolonging patient survival, and improving patient quality of life. The purpose of this study is to investigate the performance of the multi-parametric magnetic resonance imaging (mpMRI) and Dual-/Muti-energy CT and photon-counting Detector CT(PCD-CT) in the diagnosis and management of gastric cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Sep 2024

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

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Study Timeline

Key milestones and dates

Study Progress42%
Sep 2024Sep 2028

Study Start

First participant enrolled

September 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 11, 2025

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

March 6, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

CTGastric cancer

Outcome Measures

Primary Outcomes (1)

  • Diagnostic and Predictive performance of Dual-/ Muti- energy CT and MRI in the treatment response and survival prognosis of gastric cancer

    Accuracy for both imaging techniques in the prediction of treatment response of gastric cancer.

    3years

Secondary Outcomes (1)

  • The kappa value; One-way analysis of variance; ICC

    1year

Study Arms (1)

GC group

GC patients under ct and mri scan

Device: computerized tomography

Interventions

mpMRI and Photon-counting Detector CT scan

GC group

Eligibility Criteria

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

For patients undergoing radical resection, abdominal exploration or palliative tumor resection, CT scanning and dynamic contrast-enhanced magnetic resonance DCE-MRI scanning shall be completed in GSI mode before operation; for patients undergoing neoadjuvant chemotherapy, CT scanning and dynamic contrast-enhanced magnetic resonance DCE-MRI scanning shall be completed in GSI mode before neoadjuvant chemotherapy at least, and if the above scanning mode can still be used during chemotherapy, it is the best choice. Signed informed consent form. Patients who were diagnosed with gastric cancer at various medical centers were included in this study

You may qualify if:

  • Pathological biopsy confirmed gastric cancer;
  • Surgery: patients undergoing radical gastrectomy. Patients undergoing exploratory abdominal surgery or palliative tumor resection were still included in the study when peritoneal metastasis or adjacent organ invasion was identified intraoperatively and radical surgical resection was not possible.

You may not qualify if:

  • Refusal or inability to sign informed consent;
  • CT or MRI images are poor or the focus is small and CT images are not clear;
  • Patients with other tumors complicated with patients with important organ dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China, 450052, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Central Study Contacts

Zihao Zhao, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The First Affiliated Hospital of Zhengzhou University

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 11, 2025

Study Start

September 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Last Updated

March 11, 2025

Record last verified: 2024-09

Locations