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 Type
OBSERVATIONAL
Enrollment
300
The Multimodal AI System utilizes deep learning algorithms to integrate patient data from three sources: preoperative CT images (Radiomics), digitized pathology slides (Pathomics), and clinical characteristics. The model generates probability scores for: 1) Differential diagnosis of GIST vs. non-GIST, 2) Risk stratification, and 3) Genotype prediction. Note: This is an observational study. The AI model's analysis is performed in parallel to standard clinical care. The results are blinded to the treating physicians and will NOT influence the surgical plan or medical management of the participants.
The Fifth Affiliated Hospital of Anhui Medical University
Fuyang, Anhui, China
Baoding Central Hospital
Baoding, Hebei, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
Hengshui People's Hospital
Hengshui, Hebei, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Jinling Hospital
Nanjing, Jiangsu, China
Diagnostic Accuracy of the AI Model for Distinguishing GIST from Non-GIST Tumors
The diagnostic accuracy is calculated as the proportion of correctly classified patients (GIST vs. Non-GIST) by the multimodal AI model, compared to the gold standard postoperative pathological diagnosis.
Time frame: Up to 30 days post-surgery
Concordance Rate between AI-predicted Risk Grade and Pathological Modified NIH Criteria
The proportion of patients whose risk category (Very Low/Low vs. Intermediate/High) predicted by the AI model matches the actual risk grade determined by postoperative pathology according to the modified National Institutes of Health (NIH) criteria. This will be reported as a percentage (0-100%)
Time frame: Up to 30 days post-surgery
Sensitivity and Specificity of the AI Model in Predicting KIT/PDGFRA Gene Mutations
The AI model's performance in identifying specific mutations (e.g., KIT exon 11, PDGFRA) compared to the results of Next-Generation Sequencing (NGS). Data will be reported as percentages with 95% confidence intervals.
Time frame: Up to 30 days post-surgery
Area Under the Receiver Operating Characteristic Curve (AUC) for All Tasks
The AUC values will be calculated to evaluate the overall performance of the AI model in diagnosis, risk stratification, and genotype prediction. Sensitivity and Specificity will also be reported.
Time frame: Up to 30 days post-surgery
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