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Completed

NCT Number: NCT04027556

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

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Body Weight Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

low dose CT contrast media - lean body weight

Other

CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 450mgI/kg based on lean body weight.

Standard dose CT contrast media

Other

CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 560mgI/kg based on total body weight.

Primary outcomes

  1. HCC conspicuity

    Time frame: 6 months after complete enrollment

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

Secondary outcomes

  1. Image noise

    Time frame: 12 months after complete enrollment

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

  2. Image contrast

    Time frame: 12 months after complete enrollment

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

  3. Overall image quality

    Time frame: 6 months after complete enrollment

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

  4. Lesion detection

    Time frame: 12 months after complete enrollment

    assessment of focal liver lesion (HCC) on CT according to Liver Imaging Reporting and Data System (LI-RADS)

  5. Hounsfield unit

    Time frame: 3 months after complete enrollment

    measurement of hounsfield unit in aorta, portal vein, liver parenchyma, and paraspinal muscles

  6. Contrast media dose

    Time frame: 3 months after complete enrollment

    administered contrast media dose in each group

  7. Radiation dose

    Time frame: 3 months after complete enrollment

    measured radiation dose in each group

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Siemens Corporation, Corporate Technology

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Jul 22, 2019
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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