A Multicenter Randomized Controlled Trial of AI-Assisted Reading Compared With Standard Radiology Interpretation for Malignant Hepatic Lesions on Contrast-Enhanced CT: Diagnostic, Clinical and Workflow Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40,000
- 试验地点
- 1
- 主要终点
- Per-participant rate of missed clinically significant liver malignancy
研究概览
简要总结
The purpose of this multicenter pragmatic randomized controlled trial is to determine whether AI-assisted interpretation of multiphasic liver contrast-enhanced computed tomography (CE-CT) is non-inferior to standard radiology reporting with respect to missed clinically significant malignant focal liver lesions, **with the non-inferiority margin prespecified in the statistical analysis plan before enrollment**, and whether it improves lesion detection, diagnostic characterization, downstream clinical management, and reporting efficiency. On AI-assisted center-days, AI results will be revealed only after the first-line radiologist has saved an unaided initial assessment and may be used to revise the final report. On control center-days, examinations will be interpreted using the standard radiology workflow without access to AI tools.
详细描述
Multiphasic contrast-enhanced computed tomography (CE-CT) is widely used to evaluate focal liver lesions, but clinically significant malignancies may be missed or incompletely characterized. This prospective, multicenter, pragmatic, cluster-randomized, center-day crossover trial will compare AI-assisted reporting with standard radiology reporting. Center-days will be assigned in an approximately 1:1 ratio using a centrally generated randomized sequence, and each participant will receive only one workflow. In the AI-assisted arm, the radiologist will save an unaided initial assessment before the locked AI output is revealed and may revise or retain the assessment before authorizing the final report. In the control arm, examinations will be interpreted without access to AI outputs. The primary outcome will be the proportion of participants with a reference-standard-confirmed clinically significant malignant focal liver lesion that was missed or inadequately characterized in the final report. The reference standard will incorporate histopathology, follow-up imaging, multidisciplinary consensus, and relevant clinical records. Non-inferiority will be assessed using a margin prespecified in the statistical analysis plan before enrollment, followed by superiority testing if non-inferiority is demonstrated. Secondary outcomes include senior-review workload, final report turnaround time, detection rate of clinically significant malignant liver lesions, clinically appropriate management-change rate, and time to initiation of treatment for liver malignancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Age range 18 years and above
- •Underwent dynamic contrast-enhanced abdominal CT examination with liver coverage
- •Imaging must include at least three required phases: non-contrast, arterial phase, and venous phase; a delayed phase is optional
- •Complete imaging data that meet AI system and radiologist interpretation requirements.
排除标准
- •History of recent upper-abdominal surgery (within 30 days) or major hepatobiliary-pancreatic surgery affecting liver evaluation (e.g., liver transplantation or Whipple procedure); patients with prior simple cholecystectomy or single-lesion interventional procedures are not excluded
- •History of recent hepatic trauma (within 30 days)
- •Poor image quality or severe noise artifacts (e.g., metal or motion artifacts)
- •Missing required imaging phases (required at least non-contrast, arterial, and venous phases) or inadequate scan range (e.g., lower-abdomen CT such as pelvic or rectal scans not covering the liver)
研究组 & 干预措施
AI-on: AI-assisted abdominal CE-CT reporting
Intervention: AI-assisted interpretation of abdominal CE-CT
干预措施: AI-assisted abdominal CE-CT reporting (Other)
AI-off: Standard abdominal CE-CT reporting without AI assistance
Routine interpretation of abdominal CE-CT without access to AI system (standard of care)
干预措施: Standard abdominal CE-CT reporting without AI assistance (Other)
结局指标
主要结局
Per-participant rate of missed clinically significant liver malignancy
时间窗: From the index CE-CT examination through 12 months
Proportion of all enrolled participants with at least one reference-standard-confirmed clinically significant liver malignancy, including hepatocellular carcinoma, liver metastasis, or another primary hepatic malignancy, that was not identified or appropriately characterized in the final index CE-CT report. The reference standard will comprise histopathology when available; otherwise, 12-month imaging and clinical follow-up and relevant record linkage, adjudicated by an independent committee masked to allocation. Non-inferiority will be assessed against a margin prespecified before enrollment.
次要结局
- Senior-review workload(Up to 24 hours after the eligible CE-CT examination becomes available for interpretation)
- Final report turnaround time(Up to 24 hours after the complete CE-CT examination becomes available for interpretation)
- Detection rate of clinically significant malignant liver lesions(From the index CE-CT examination through 12 months)
- Clinically appropriate management-change rate(From the index CE-CT examination through 12 months)
- Time to initiation of treatment for liver malignancy(From the index CE-CT examination through 12 months)
研究者
Yu Shi
Professor of Radiology
Shengjing Hospital