AI-Based Prediction of Lymph Node Metastasis in Gastric Cancer Using Preoperative Multimodal Data

NCT ID: NCT06957678

Last Updated: 2025-05-04

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

ENROLLING_BY_INVITATION

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-31

Brief Summary

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

This study aims to develop and validate an artificial intelligence (AI) system that can predict whether lymph node metastasis has occurred in patients with gastric cancer before surgery. Using preoperative imaging and pathology data, the AI models will not only predict if metastasis is present but also identify which specific lymph node stations or individual lymph nodes are involved. All lymph nodes will be carefully removed during surgery and examined one by one with detailed pathological methods to ensure accurate diagnosis. The goal is to improve the accuracy of lymph node assessment and assist doctors in making better treatment decisions.

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 Adenocarcinoma Metastatic Lymph Node Metastasis Artificial Intelligence (AI) in Diagnosis

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

Artificial Intelligence-Based Predictive Model for Lymph Node Metastasis

The intervention is an artificial intelligence-based predictive model developed using preoperative multimodal data, including contrast-enhanced CT images, preoperative histopathological findings, and clinical features. The model is designed to predict (1) the presence or absence of lymph node metastasis, (2) the specific lymph node stations involved, and (3) the individual lymph nodes involved. Each lymph node's metastatic status is confirmed by serial pathological sectioning of surgically retrieved nodes, ensuring a highly accurate reference standard for model training and validation. This distinguishes the intervention from traditional imaging-based assessments and from other AI models that do not use individually validated lymph node pathology.

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

* Age 18 years or older

Histologically confirmed gastric adenocarcinoma

Scheduled for curative-intent gastrectomy with lymphadenectomy

Completed preoperative imaging with contrast-enhanced CT or MRI

Available preoperative biopsy pathology report

Able and willing to provide written informed consent

Exclusion Criteria

* Evidence of distant metastasis on preoperative imaging

Prior chemotherapy, radiotherapy, or major abdominal surgery

Severe comorbidities contraindicating surgery

Incomplete or poor-quality preoperative imaging or pathology data

Pregnancy or lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

Nanjing University School of Medicine

OTHER

Sponsor Role collaborator

Baoding First Central Hospital

OTHER

Sponsor Role collaborator

Hengshui People's Hospital

OTHER

Sponsor Role collaborator

No.1 Hospital of Shijiazhuang City

UNKNOWN

Sponsor Role collaborator

The Second Affiliated Hospital of Xingtai Medical College

UNKNOWN

Sponsor Role collaborator

Qun Zhao

OTHER

Sponsor Role lead

Responsible Party

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

Qun Zhao

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

the Fourth Hospital of Hebei Medical University

Shijiazhuang, None Selected, China

Site Status

Countries

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

China

Other Identifiers

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

GC-RAD-AI-2025-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.