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

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

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.

Study Overview

• Status: Completed
• Conditions: Body Weight; Carcinoma, Hepatocellular
• Intervention / Treatment: Other: low dose CT contrast media - lean body weight; Other: Standard dose CT contrast media

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 keV DLD images of the LBW-based low-dose group; Low CT contrast media dose calculated based on lean body weight and low monoenergetic images of dual-energy CT with deep learning-based denoising	Other: low dose CT contrast media - lean body weight; CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 450mgI/kg based on lean body weight.
Active Comparator: ADMIRE images of the standard-contrast dose group; Standard CT contrast media dose calculated based on total body weight and conventional images with full model-based iterative reconstruction	Other: Standard dose CT contrast media; CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 560mgI/kg based on total body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCC conspicuity	qualitative scoring for focal lesion depiction on four-point scale (1: worst, 4: excellent, representative value is average score)	6 months after complete enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Siemens Corporation, Corporate Technology

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Actual): August 26, 2020
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Body Weight
• Other Study ID Numbers: SNUH-2019-0344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No