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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04027556
Enrollment
90
Registered
2019-07-22
Start date
2019-06-27
Completion date
2022-02-10
Last updated
2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Weight, Carcinoma, Hepatocellular

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.

Interventions

OTHERlow 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.

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

Sponsors

Siemens Corporation, Corporate Technology
CollaboratorINDUSTRY
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HCC conspicuity6 months after complete enrollmentqualitative scoring for focal lesion depiction on four-point scale (1: worst, 4: excellent, representative value is average score)

Secondary

MeasureTime frameDescription
Image contrast12 months after complete enrollmentqualitative scoring for image contrast on four-point scale (1: worst, 4: excellent, representative value is average score)
Overall image quality6 months after complete enrollmentqualitative scoring for image quality on four-point scale (1: worst, 4: excellent, representative value is average score)
Lesion detection12 months after complete enrollmentassessment of focal liver lesion (HCC) on CT according to Liver Imaging Reporting and Data System (LI-RADS)
Image noise12 months after complete enrollmentqualitative scoring for image noise on four-point scale (1: worst, 4: excellent, representative value is average score)
Contrast media dose3 months after complete enrollmentadministered contrast media dose in each group
Radiation dose3 months after complete enrollmentmeasured radiation dose in each group
Hounsfield unit3 months after complete enrollmentmeasurement of hounsfield unit in aorta, portal vein, liver parenchyma, and paraspinal muscles

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026