Low Contrast Agent and Radiation Dose Protocol Liver CT With Deep-learning-based Contrast Boosting Model in Patients at High Risk for HCC: Prospective, Randomized, Single Blinded - Preliminary 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
- Detection rate of solid focal lesion in liver
研究概览
简要总结
The purpose of this study is to investigate the image quality and clinical feasibility of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.
详细描述
The purpose of this study is to investigate the image quality (CNR, subjective inage quality, vessel and lesion conspicuity) and clinical feasibility (rate of lesion detection) of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.
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 (Care Provider)
盲法说明
Participants, investigators, and outcome assessors were all masked to the allocation
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis
- •Tumor marker (aFP, PIVKA) elevation
- •Nodular lesion on USG
- •Received RFA for HCC
排除标准
- •hypersensitivity at iodine
- •GFR under 30
- •BMI over 30
- •Nursing or pregnant women
- •enrolled the other study
研究组 & 干预措施
Conventional liver CT
Underwent conventional liver CT on HCC high-risk patient
干预措施: Conventional CT (radiation) (Radiation)
Conventional liver CT
Underwent conventional liver CT on HCC high-risk patient
干预措施: Conventional CT (contrast agent) (Drug)
Double low dose CT
Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient
干预措施: Low radiation dose CT (Radiation)
Double low dose CT
Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient
干预措施: Low contrast dose CT (Drug)
Double low dose CT
Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient
干预措施: Deep-learning based contrast boosting algorithms (Other)
结局指标
主要结局
Detection rate of solid focal lesion in liver
时间窗: 12 months after last patient's image work up
diagnostic performance
Quantitative image quality analysis
时间窗: Immediate after study enrollement
Contrast-to-Noise
次要结局
未报告次要终点
研究者
Jeong Min Lee
Professor
Seoul National University Hospital