NCT05790590招募中不适用
Comparison of Image Quality Between "Double Low Dose" Liver CT Using AI-based Iodine Boosting Reconstruction and Standard Contrast-enhanced Liver CT in Patients With Colorectal Cancer: Prospective, Randomized, Non-inferiority Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- lesion conspicuity on portal venous phase
研究概览
简要总结
In patients with malignancies, contrast-enhanced abdominal CT (hereafter abdominal CT) plays an important role in detecting carcinoma recurrence and assessing treatment response. In this study, we aim to investigate whether such a "double low" dose CT is feasible in patients with liver metastases of colorectal cancer using a vendor-agnostic artificial intelligence-based noise reduction and contrast enhancement software.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •colorectal cancer (CRC) patients
- •on surveillance or monitoring for liver metastasis (of CRC)
排除标准
- •any relative or absolute contra-indication of CECT
- •diffuse infiltrative type of liver metastasis or on monitoring for too many liver lesions
结局指标
主要结局
lesion conspicuity on portal venous phase
时间窗: 6 months after primary study completion.
qualitative analysis of lesion conspicuity on portal venous phase on five-point scale (higher score indicates better conspicuity). Lesion conspicuity is compared between the two arms.
次要结局
- Radiation dose(1 month after primary study completion)
- lesion conspicuity on arterial phase(6 months after primary study completion.)
- Contrast media (CM) dose(1 month after primary study completion)
- lesion detectability(12 months after primary study completion.)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital
研究点 (2)
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