Clinical trial NCT04027556: Low-contrast Dose Liver CT Using Lean Body Weight Low Monoenergetic Images and Deep Learning-based Reconstruction
Official title: Low-contrast Dose Liver CT Using Lean Body Weight, Low Monoenergetic Images and Deep Learning-based Reconstruction for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Body Weight
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Siemens Corporation, Corporate Technology
First posted: 2019-07-22
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: HCC conspicuity
timeFrame: 6 months after complete enrollment
Secondary outcomes:
measure: Image noise
timeFrame: 12 months after complete enrollment
measure: Image contrast
timeFrame: 12 months after complete enrollment
measure: Overall image quality
timeFrame: 6 months after complete enrollment
measure: Lesion detection
timeFrame: 12 months after complete enrollment
measure: Hounsfield unit
timeFrame: 3 months after complete enrollment
measure: Contrast media dose
timeFrame: 3 months after complete enrollment
measure: Radiation dose
timeFrame: 3 months after complete enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: