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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 1
- 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
研究组 & 干预措施
Standard dose CT
Standard dose protocol CT using standard radiation dose (120 kVp) and standard dose of contrast media, and reconstructed with commercially available reconstruction algorithm of the CT scanner.
干预措施: Standard dose CT (Diagnostic Test)
Double low dose CT
Double low dose protocol CT using low radiation dose (120 kVp & 70% of reference mAs of standard dose CT) and low dose of contrast media, and reconstructed with commercially available vendor-agonistic AI-based software.
干预措施: Double low dose CT (Diagnostic Test)
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