Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:39 AM
Study NCT ID:
NCT07454967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Multimodal AI System for GIST Management
Sponsor:
Qun Zhao
Organization:
Study Overview
Official Title:
Development and Validation of a Multimodal Artificial Intelligence Model Integrating CT Radiomics, Pathomics, and Clinical Features for the Diagnosis, Risk Stratification, and Genotype Prediction of Gastrointestinal Stromal Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background: Gastrointestinal Stromal Tumors (GISTs) are the most common mesenchymal tumors of the gastrointestinal tract. Accurate pre-operative diagnosis, risk stratification, and genotyping are critical for determining the appropriate surgical approach and targeted therapy (such as Imatinib). However, current methods often rely on invasive postoperative pathology and expensive genetic testing.
Study Objective: The purpose of this study is to develop and validate a multimodal Artificial Intelligence (AI) model that integrates clinical data, CT radiomics (imaging features), and pathomics (digital pathology features) to improve the precision of GIST management.
Study Design: This is a prospective, observational study. The researchers will recruit patients with suspected gastric submucosal tumors who are scheduled for surgery or biopsy at The Fourth Hospital of Hebei Medical University.
Core Tasks: The AI model will be trained to perform three specific tasks:
Diagnosis: Distinguish GISTs from other non-GIST mesenchymal tumors (e.g., leiomyomas, schwannomas).
Risk Assessment: Stratify GISTs into risk categories (e.g., Low vs. High risk) to predict malignant potential.
Genotyping: Predict specific gene mutations (e.g., KIT or PDGFRA mutations) to guide immunotherapy or targeted therapy.
Methodology: Patient data (CT scans, pathology slides, and clinical history) will be collected and analyzed by the AI system. The AI's predictions will be compared against the "Gold Standard" results derived from postoperative pathological examination and Next-Generation Sequencing (NGS). This study is non-interventional; the AI results will not affect the standard of care received by the patients.
Study Objective: The purpose of this study is to develop and validate a multimodal Artificial Intelligence (AI) model that integrates clinical data, CT radiomics (imaging features), and pathomics (digital pathology features) to improve the precision of GIST management.
Study Design: This is a prospective, observational study. The researchers will recruit patients with suspected gastric submucosal tumors who are scheduled for surgery or biopsy at The Fourth Hospital of Hebei Medical University.
Core Tasks: The AI model will be trained to perform three specific tasks:
Diagnosis: Distinguish GISTs from other non-GIST mesenchymal tumors (e.g., leiomyomas, schwannomas).
Risk Assessment: Stratify GISTs into risk categories (e.g., Low vs. High risk) to predict malignant potential.
Genotyping: Predict specific gene mutations (e.g., KIT or PDGFRA mutations) to guide immunotherapy or targeted therapy.
Methodology: Patient data (CT scans, pathology slides, and clinical history) will be collected and analyzed by the AI system. The AI's predictions will be compared against the "Gold Standard" results derived from postoperative pathological examination and Next-Generation Sequencing (NGS). This study is non-interventional; the AI results will not affect the standard of care received by the patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: