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

Not Applicable

Completed

• Conditions: Body Weight; Carcinoma, Hepatocellular
• Interventions: Other: low dose CT contrast media - lean body weight; Other: Standard dose CT contrast media

• Registration Number: NCT04027556
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-06-27
• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-22
• Primary Completion: 2020-08-26
• Study Completion: 2022-02-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 keV DLD images of the LBW-based low-dose group	low dose CT contrast media - lean body weight	Low CT contrast media dose calculated based on lean body weight and low monoenergetic images of dual-energy CT with deep learning-based denoising
ADMIRE images of the standard-contrast dose group	Standard dose CT contrast media	Standard CT contrast media dose calculated based on total body weight and conventional images with full model-based iterative reconstruction

Primary Outcome Measures

Name	Time	Method
HCC conspicuity	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 Outcome Measures

Name	Time	Method
Image contrast	12 months after complete enrollment	qualitative scoring for image contrast on four-point scale (1: worst, 4: excellent, representative value is average score)
Lesion detection	12 months after complete enrollment	assessment of focal liver lesion (HCC) on CT according to Liver Imaging Reporting and Data System (LI-RADS)
Hounsfield unit	3 months after complete enrollment	measurement of hounsfield unit in aorta, portal vein, liver parenchyma, and paraspinal muscles
Image noise	12 months after complete enrollment	qualitative scoring for image noise on four-point scale (1: worst, 4: excellent, representative value is average score)
Contrast media dose	3 months after complete enrollment	administered contrast media dose in each group
Overall image quality	6 months after complete enrollment	qualitative scoring for image quality on four-point scale (1: worst, 4: excellent, representative value is average score)
Radiation dose	3 months after complete enrollment	measured radiation dose in each group

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of