Comparison of Image Quality Between "Double Low-Dose" Dual Energy Liver CT and Standard Contrast Enhanced Liver CT in Patients at High-risk of HCC: Prospective, Randomized Single Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Lesion conspicuity
研究概览
简要总结
Hypothesis: double low-dose protocol provide better lesion conspicuity than standard protocol CT in patients at high-risk of HCC.
patients who are scheduled for CECT for HCC diagnosis or surveillance are eligible for this study and allocated to either standard protocol or double-low dose protocol using spectral CT with low radiation dose and low dose of contrast media, within clinically accpetable range.
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
- •high risk of HCC (chronic hepatitis B or C, or LC of any cause)
- •signed informed consent
- •scheduled for contrast enhanced liver CT for HCC surveillance or diagnosis
排除标准
- •no risk factor for HCC
- •history of iodine hypersensitivity
- •renal dysfunction (Estimated GFR < 30mL/min/1.73m2) or on dialysis
- •metformin medication within 48 hours
- •any other contraindication of CE-CT
- •BMI > or = 30
研究组 & 干预措施
Double Low-Dose protocol CT
Low radiation dose + low amount of iodine contrast media at spectral CT (Philips Healthcare)
干预措施: Double Low-Dose protocol CT (Diagnostic Test)
Standard protocol CT
Standard protocol quadriphasic liver CT according to current liver CT protocol in our institution, at spectral CT (Philips Healthcare)
干预措施: Standard protocol CT (Diagnostic Test)
结局指标
主要结局
Lesion conspicuity
时间窗: 12 months after CT
qualitative conspicuity assessment of focal liver lesion
次要结局
- beam hardening artifact(12 months after CT)
- hepatic artery conspicuity(12 months after CT)
- image texture (plasticity)(12 months after CT)
- sensitivity to detect HCC(18 months after CT)
- image noise(12 months after CT)
- radiation dose(1 month after CT)
- portal vein conspicuity(12 months after CT)
- overall image quality(12 months after CT)
- presence of hepatic artery anatomic variation(12 months after CT)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital