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临床试验/NCT04027556
NCT04027556已完成不适用

Low-contrast Dose Liver CT Using Lean Body Weight, Low Monoenergetic Images and Deep Learning-based Reconstruction for Hepatocellular Carcinoma

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
HCC conspicuity

研究概览

简要总结

This study aims to assess whether the acceptable image quality is achievable using low monoenergetic imaging of dual-energy CT with deep learning-based denoising, and low contrast media dose calculated based on lean body weight for the detection of hepatocellular carcinoma.

详细描述

The use of iodinated contrast media in CT is associated with an immediate hypersensitivity reaction in a dose-dependent manner. Therefore, it is important to reduce the contrast dose for CT exams in patients who are required repeated CT examinations, including patients with hepatocellular carcinoma (HCC). Low monoenergetic images of dual-energy CT can provide higher iodine contrast than conventional images, thus enabling reduction of contrast media. The high image noise in low monoenergetic images may be improved by using model-based IR techniques and deep learning-based denoising (DLD) algorithms. Besides, lean body weight (LBW)-based contrast dose determination can be another option to reduce contrast media dose compared with total body weight-based dose determination since the volumes of blood and liver are not strictly proportional to total body weight. Therefore, we surmised that 50 keV images reconstructed with DLD algorithms with reducing iodine load by 30% based on LBW could produce the comparable image quality and lesion conspicuity compared with standard iodine-dose 120kVp images.

In this single-center prospective, randomized clinical trial, we aimed to investigate the effectiveness of low-contrast dose CT using 50 keV and DLD technique compared with the standard contrast-dose protocol using model-based IR in patients at high risk of HCC.

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
Double (Participant, 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

入选标准

  • High risk group for developing HCC
  • Scheduled contrast-enhanced CT for HCC diagnosis or surveillance

排除标准

  • not a high risk group for developing HCC
  • body mass index is equal to or larger than 30 kg/m^2
  • suspected HCC > 5cm in diameter
  • received locoregional treatment or surgery for HCC within 3 months
  • congestive hepatopathy
  • no venous access on forearm
  • anticipated beam hardening artifact due to prosthesis
  • relative/absolute contraindication of contrast-enhanced CT

结局指标

主要结局

HCC conspicuity

时间窗: 6 months after complete enrollment

qualitative scoring for focal lesion depiction on four-point scale (1: worst, 4: excellent, representative value is average score)

次要结局

  • Image contrast(12 months after complete enrollment)
  • Lesion detection(12 months after complete enrollment)
  • Hounsfield unit(3 months after complete enrollment)
  • Image noise(12 months after complete enrollment)
  • Contrast media dose(3 months after complete enrollment)
  • Overall image quality(6 months after complete enrollment)
  • Radiation dose(3 months after complete enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong Min Lee

Professor

Seoul National University Hospital

研究点 (1)

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