跳至主要内容
临床试验/NCT07445152
NCT07445152尚未招募不适用

Research on Construction and Verification of Multimodal Medical Imaging Large Model

Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 2,000 人开始时间: 2026年11月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
2,000
主要终点
Disease Diagnosis Task

研究概览

简要总结

With the accumulation of multimodal clinical data such as medical imaging and electronic health records (EHRs), efficient utilization of multi-source information to achieve precise diagnosis and intelligent decision-making has become a core direction of medical artificial intelligence (AI). Although traditional unimodal algorithms have yielded outcomes in specific tasks, their inability to model the semantic correlations among imaging, textual, and laboratory data leads to insufficient stability and limited interpretability of diagnostic results, making it difficult to meet the needs of comprehensive decision-making in complex clinical scenarios.

In recent years, multimodal large models have demonstrated excellent cross-modal understanding and knowledge transfer capabilities in natural images and general vision-language tasks, providing a new paradigm for medical AI. However, direct application in medical scenarios still faces challenges: first, the medical semantic system differs significantly from general language models, hindering the accurate representation of disease characteristics and imaging details; second, the complex morphology of lesions and uneven sample distribution in medical data increase the difficulty of model generalization; third, clinical data involves privacy, so data security and ethical compliance serve as prerequisites for research.

The research on medical multimodal large models aims to integrate multi-source heterogeneous medical data, establish a unified semantic representation and reasoning mechanism, and realize full-process intelligent analysis including disease identification and lesion localization. This approach can not only improve the efficiency and accuracy of clinical diagnosis but also provide clinicians with interpretable and traceable auxiliary decision support, boasting broad application prospects.

Based on the hospital's clinical data resources and the research team's algorithmic foundation, this study intends to construct a multimodal large model system for medical imaging diagnosis, enabling closed-loop intelligent analysis from multimodal information fusion to diagnostic report generation. The research will strictly adhere to medical ethical standards, protect patients' right to information, right to privacy, and data security. Before the official launch of the project, ethical review must be passed, and relevant regulations shall be followed to ensure the unity of scientific research and ethics, laying a compliant foundation for subsequent clinical validation and promotion.

详细描述

With the continuous accumulation of medical imaging, electronic health records (EHRs), and multimodal clinical data, how to efficiently leverage multi-source medical information to achieve precise diagnosis and intelligent decision-making has become a core direction in the development of medical artificial intelligence (AI). Although traditional unimodal algorithms (e.g., models based solely on CT, MRI, or ultrasound images) have yielded certain results in specific tasks, their inability to model semantic correlations among imaging, textual, and laboratory data often leads to insufficient stability and limited interpretability of diagnostic outcomes, making it difficult to meet the comprehensive decision-making needs of complex clinical scenarios.

In recent years, multimodal large language models (MLLMs) have demonstrated remarkable cross-modal understanding and knowledge transfer capabilities in natural image processing and general vision-language tasks, providing a new technical paradigm for medical AI. However, the direct application of such models in medical scenarios still faces multiple challenges: first, there are significant discrepancies between the medical semantic system and general language models, hindering the accurate representation of disease characteristics and imaging details; second, the complex morphology of lesions and imbalanced sample distribution in medical data increase the difficulty of model generalization; third, clinical data involves privacy-sensitive information, making data security and ethical compliance a prerequisite for research.

Research on medical multimodal large models aims to comprehensively utilize multi-source heterogeneous data-such as medical imaging (e.g., CT, MRI, X-ray), EHRs, and laboratory reports-to establish a unified semantic representation and reasoning mechanism, enabling end-to-end intelligent analysis including disease identification, lesion localization, report generation, and disease progression prediction. This research direction not only helps improve the efficiency and accuracy of clinical diagnosis but also provides clinicians with interpretable and traceable auxiliary decision support, boasting broad prospects for clinical application.

Based on the hospital's abundant clinical data resources and the research team's algorithm development foundation, this study intends to construct a multimodal large model system for medical imaging diagnosis, realizing a closed-loop intelligent analysis pipeline from multimodal information fusion to diagnostic report generation.

During the research implementation, strict adherence to medical ethical standards will be followed to fully protect patients' right to informed consent, privacy, and data security. To ensure the scientificity and compliance of the research design, this project must pass ethical review prior to its official launch. In accordance with relevant regulations including the Declaration of Helsinki, International Ethical Guidelines for Health-related Research Involving Humans, and Ethical Review Measures for Life Science and Medical Research Involving Humans, we will achieve the organic integration of scientific research and ethical principles, laying a compliant foundation for subsequent clinical validation and application promotion.

研究设计

研究类型
Observational
观察模型
Other
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

  • Adult patients aged ≥ 18 years.
  • Patients who underwent imaging examinations (CT, MRI, ultrasound, etc.) at this hospital during the study period.
  • The examination items are consistent with the disease types or systems focused on by the study (hepatobiliary and pancreatic system).
  • Possess at least complete imaging data, radiological diagnostic reports, with relevant medical record information as supplementary modalities.
  • Patients and their legal representatives have signed an informed consent form, agreeing to the use of their de-identified data for scientific research model validation.

排除标准

  • Patients who refuse to sign the informed consent form.
  • Cases with unassessable images due to severe motion artifacts, incomplete scanning, or equipment abnormalities.
  • Cases with severe deficiency of clinical data or failure to match with imaging data.
  • Cases with special pathological conditions or post-operative status (e.g., extensive resection, significant structural changes after radiotherapy) that affect the consistency of model analysis.
  • Data samples with privacy protection or legal risks.

研究组 & 干预措施

Group1:This study enrolled adult patients aged ≥ 18 years who underwent imaging examinations (includ

结局指标

主要结局

Disease Diagnosis Task

时间窗: From enrollment to the end of diagnosis at 3 days

The primary outcome is the accuracy and reliability of the multimodal imaging diagnostic model in identifying and classifying target diseases compared with the gold standard of clinical diagnosis by senior radiologists.

Lesion Localization and Segmentation Task

时间窗: from enrollment to end of diagnosis up to 3 days

It includes the model's performance in precise localization, contour segmentation and quantitative measurement of lesions, assessed by Dice similarity coefficient, IoU and localization error.

Diagnostic Report Generation Task

时间窗: from enrollment to end of diagnosis up to 3 days

It evaluates the clinical validity, completeness, consistency and readability of automatically generated radiology reports relative to manual reports.

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

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