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临床试验/NCT07340762
NCT07340762进行中(未招募)不适用

Multi-step Automated Report Generation of Cardiovascular Magnetic Resonance Imaging Based on Visual Large Language Model

Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
20,000
试验地点
1
主要终点
Diagnostic Accuracy of AI-Generated Cardiac MRI Reports

研究概览

简要总结

The goal of this observational study is to evaluate the accuracy, completeness, and clinical consistency of large language model-generated cardiac magnetic resonance (CMR) imaging reports compared with expert radiologist reports in patients undergoing routine clinical CMR examinations.

The main question(s) it aims to answer are:

Can automatically generated CMR reports produced by a large multimodal model accurately reflect key imaging findings and diagnoses when compared with reports written by experienced cardiovascular radiologists?

How does the quality of generated reports perform in terms of clinical correctness, completeness, and linguistic clarity, as assessed by quantitative metrics and expert review?

If there is a comparison group:

Researchers will compare AI-generated CMR reports with ground-truth reports authored by board-certified cardiovascular radiologists to see if the automated system achieves comparable diagnostic accuracy and report quality across different cardiac pathologies.

Participants will:

Undergo standard-of-care cardiac MRI examinations as part of routine clinical practice.

Have their anonymized CMR image data and corresponding radiologist reports retrospectively collected.

Contribute data that will be used to generate automated CMR reports, which will then be evaluated against expert reports using objective metrics (e.g., diagnostic agreement, entity-level accuracy) and subjective clinical scoring by radiologists.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who underwent clinically indicated cardiac magnetic resonance (CMR) examinations.
  • Availability of complete and de-identified CMR image data.
  • Availability of corresponding clinical CMR reports authored by experienced cardiovascular radiologists.
  • CMR studies acquired using standard clinical imaging protocols.

排除标准

  • Incomplete or corrupted CMR image data.
  • Absence of a reference radiologist report.
  • Poor image quality that precludes reliable clinical interpretation.
  • CMR studies with severe imaging artifacts affecting diagnostic evaluation.

结局指标

主要结局

Diagnostic Accuracy of AI-Generated Cardiac MRI Reports

时间窗: Single time point (retrospective analysis)

The primary outcome is the diagnostic accuracy of automatically generated cardiac magnetic resonance (CMR) reports produced by a large multimodal model. Diagnostic accuracy is assessed by comparing AI-generated reports with reference reports written by board-certified cardiovascular radiologists. Agreement is evaluated at the level of key clinical findings and final imaging impressions, using predefined criteria. Accuracy metrics include correctness of major diagnoses and presence or absence of clinically relevant imaging findings.

次要结局

未报告次要终点

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Minjie Lu

Chief Doctor

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (1)

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