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

NCT04027556 | Completed DMC

• 1 other identifier: SNUH-2019-0344
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular; Body Weight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Image noise

  12 months after complete enrollment

• Image contrast

  12 months after complete enrollment

• Overall image quality

  6 months after complete enrollment

• Lesion detection

  12 months after complete enrollment

• Hounsfield unit

  3 months after complete enrollment

Study Arms (2)

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

EXPERIMENTAL

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

ADMIRE images of the standard-contrast dose group

ACTIVE COMPARATOR

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

Interventions

low dose CT contrast media - lean body weight OTHER

CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 450mgI/kg based on lean body weight.

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

Standard dose CT contrast media OTHER

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

ADMIRE images of the standard-contrast dose group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High risk group for developing HCC
• Scheduled contrast-enhanced CT for HCC diagnosis or surveillance

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Body Weight

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeong Min Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: June 27, 2019
• Primary Completion: August 26, 2020
• Study Completion: February 10, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)