Prospective User Study and Multicenter Validation of Multimodal Medical Imaging Large Models in the Diagnosis of Common Systemic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Case-level Diagnostic Accuracy and Area Under the ROC Curve (AUC)
研究概览
简要总结
Following model development and locking, the fixed model is evaluated in prospectively collected CT cohorts from two centers. The study is observational and does not affect clinical care. A subset of cases is used in a randomized crossover reader study.
详细描述
After model locking, CT data are prospectively collected at two centers for observational validation without retraining or parameter adjustment. Model outputs do not influence patient management. A subset of eligible cases is selected for the randomized crossover reader study.
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
- 是
入选标准
- •Patients who underwent CT examinations for common systemic diseases.
- •Imaging data must have confirmed clinical reference standards, expert consensus, or pathological diagnosis.
- •Availability of complete DICOM format images with standard acquisition protocols.
排除标准
- •Poor image quality (e.g., severe motion or metal artifacts) that precludes definitive diagnosis.
- •Cases with incomplete clinical or pathological reference standards.
- •Corrupted image files or duplicate cases.
研究组 & 干预措施
Validation Cohort
Prospective Observational Validation Cohorts CT data are prospectively collected at two centers after model locking and used for observational model validation. A subset is included in the randomized crossover reader study.
干预措施: Standalone Radiologist Interpretation (Other)
Validation Cohort
Prospective Observational Validation Cohorts CT data are prospectively collected at two centers after model locking and used for observational model validation. A subset is included in the randomized crossover reader study.
干预措施: AI-assisted Radiologist Interpretation (Other)
结局指标
主要结局
Case-level Diagnostic Accuracy and Area Under the ROC Curve (AUC)
时间窗: Up to 1 week per evaluation period
Evaluation of case-level diagnostic accuracy (defined as the proportion of diagnostic decisions matching the clinical ground-truth label) and discrimination performance (measured by AUC) to compare unaided radiologist performance versus AI-assisted performance.
次要结局
- Diagnostic Efficiency (Reading and Reporting Time)(Up to 1 week per evaluation period)
- Inter-rater Agreement (Fleiss' Kappa)(Up to 1 week per evaluation period)
- Clinical Report Quality and Semantic Accuracy Score(Up to 1 week per evaluation period)
研究者
Junyan Li
Scientific Research Administrator
The Third Affiliated Hospital of Southern Medical University