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临床试验/NCT07454967
NCT07454967已完成不适用

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

Qun Zhao9 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
9
主要终点
Diagnostic Accuracy of the AI Model for Distinguishing GIST from Non-GIST Tumors

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years, gender not limited.
  • Clinical diagnosis of gastric submucosal tumor (SMT) or suspected gastrointestinal stromal tumor (GIST) based on gastroscopy or ultrasound.
  • Scheduled for surgical resection or endoscopic biopsy at the study center.
  • Standard preoperative contrast-enhanced CT scans are available (performed within 2 weeks prior to surgery).
  • Patients or their legal guardians have signed the informed consent form.

排除标准

  • Received neoadjuvant therapy (e.g., Imatinib, chemotherapy, or radiotherapy) prior to surgery/biopsy.
  • Poor quality of CT images (e.g., severe motion artifacts) affecting radiomics analysis.
  • Insufficient tissue samples for pathological diagnosis or genetic testing.
  • Confirmed diagnosis of other primary malignancies.
  • Incomplete clinical data or lost to follow-up immediately after surgery.

结局指标

主要结局

Diagnostic Accuracy of the AI Model for Distinguishing GIST from Non-GIST Tumors

时间窗: Up to 30 days post-surgery

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.

次要结局

  • Concordance Rate between AI-predicted Risk Grade and Pathological Modified NIH Criteria(Up to 30 days post-surgery)
  • Sensitivity and Specificity of the AI Model in Predicting KIT/PDGFRA Gene Mutations(Up to 30 days post-surgery)
  • Area Under the Receiver Operating Characteristic Curve (AUC) for All Tasks(Up to 30 days post-surgery)

研究者

发起方
Qun Zhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Qun Zhao

Professor

Hebei Medical University

研究点 (9)

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