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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04027556
Collaborator
Siemens Corporation, Corporate Technology (Industry)
90
1
2
31.5
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: low dose CT contrast media - lean body weight
  • Other: Standard dose CT contrast media
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Low-contrast Dose Liver CT Using Lean Body Weight, Low Monoenergetic Images and Deep Learning-based Reconstruction for Hepatocellular Carcinoma
Actual Study Start Date :
Jun 27, 2019
Actual Primary Completion Date :
Aug 26, 2020
Actual Study Completion Date :
Feb 10, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Hounsfield unit [3 months after complete enrollment]

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

  6. Contrast media dose [3 months after complete enrollment]

    administered contrast media dose in each group

  7. Radiation dose [3 months after complete enrollment]

    measured radiation dose in each group

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital
  • Siemens Corporation, Corporate Technology

Investigators

  • Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeong Min Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04027556
Other Study ID Numbers:
  • SNUH-2019-0344
First Posted:
Jul 22, 2019
Last Update Posted:
May 4, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2022