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

Primary Purpose

Carcinoma, Hepatocellular, Body Weight

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
low dose CT contrast media - lean body weight
Standard dose CT contrast media
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carcinoma, Hepatocellular

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

50 keV DLD images of the LBW-based low-dose group

ADMIRE images of the standard-contrast dose group

Arm Description

Low CT contrast media dose calculated based on lean body weight and low monoenergetic images of dual-energy CT with deep learning-based denoising

Standard CT contrast media dose calculated based on total body weight and conventional images with full model-based iterative reconstruction

Outcomes

Primary Outcome Measures

HCC conspicuity
qualitative scoring for focal lesion depiction on four-point scale (1: worst, 4: excellent, representative value is average score)

Secondary Outcome Measures

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

Full Information

First Posted
July 18, 2019
Last Updated
April 27, 2022
Sponsor
Seoul National University Hospital
Collaborators
Siemens Corporation, Corporate Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04027556
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
August 26, 2020 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Siemens Corporation, Corporate Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular, Body Weight

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50 keV DLD images of the LBW-based low-dose group
Arm Type
Experimental
Arm Description
Low CT contrast media dose calculated based on lean body weight and low monoenergetic images of dual-energy CT with deep learning-based denoising
Arm Title
ADMIRE images of the standard-contrast dose group
Arm Type
Active Comparator
Arm Description
Standard CT contrast media dose calculated based on total body weight and conventional images with full model-based iterative reconstruction
Intervention Type
Other
Intervention Name(s)
low dose CT contrast media - lean body weight
Intervention Description
CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 450mgI/kg based on lean body weight.
Intervention Type
Other
Intervention Name(s)
Standard dose CT contrast media
Intervention Description
CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 560mgI/kg based on total body weight.
Primary Outcome Measure Information:
Title
HCC conspicuity
Description
qualitative scoring for focal lesion depiction on four-point scale (1: worst, 4: excellent, representative value is average score)
Time Frame
6 months after complete enrollment
Secondary Outcome Measure Information:
Title
Image noise
Description
qualitative scoring for image noise on four-point scale (1: worst, 4: excellent, representative value is average score)
Time Frame
12 months after complete enrollment
Title
Image contrast
Description
qualitative scoring for image contrast on four-point scale (1: worst, 4: excellent, representative value is average score)
Time Frame
12 months after complete enrollment
Title
Overall image quality
Description
qualitative scoring for image quality on four-point scale (1: worst, 4: excellent, representative value is average score)
Time Frame
6 months after complete enrollment
Title
Lesion detection
Description
assessment of focal liver lesion (HCC) on CT according to Liver Imaging Reporting and Data System (LI-RADS)
Time Frame
12 months after complete enrollment
Title
Hounsfield unit
Description
measurement of hounsfield unit in aorta, portal vein, liver parenchyma, and paraspinal muscles
Time Frame
3 months after complete enrollment
Title
Contrast media dose
Description
administered contrast media dose in each group
Time Frame
3 months after complete enrollment
Title
Radiation dose
Description
measured radiation dose in each group
Time Frame
3 months after complete enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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