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Completed

NCT Number: NCT04722120

Low Contrast Agent and Radiation Dose Protocol for Liver CT in Patients With HCC

The purpose of this study is to investigate the image quality and clinical feasibility of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

The purpose of this study is to investigate the image quality (CNR, subjective inage quality, vessel and lesion conspicuity) and clinical feasibility (rate of lesion detection) of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Liver cirrhosis
  • Tumor marker (aFP, PIVKA) elevation
  • Nodular lesion on USG
  • Received RFA for HCC

Exclusion criteria

  • hypersensitivity at iodine
  • GFR under 30
  • BMI over 30
  • Nursing or pregnant women
  • enrolled the other study

Treatment and study plan

Low radiation dose CT

Radiation

Underwent liver CT with 30% lower radiation dose

Conventional CT (radiation)

Radiation

Underwent liver CT without change of radiation.

Low contrast dose CT

Drug

Underwent liver CT 20% lower dose contrast media.

Other names: Low contrast medium dosage

Conventional CT (contrast agent)

Drug

Underwent liver CT without change of contrast media doses.

Other names: Standard contrast medium dosage

Deep-learning based contrast boosting algorithms

Other

Applied deep-learning based contrast boosting algorithms on acquired CT images

Primary outcomes

  1. Detection rate of solid focal lesion in liver

    Time frame: 12 months after last patient's image work up

    diagnostic performance

  2. Quantitative image quality analysis

    Time frame: Immediate after study enrollement

    Contrast-to-Noise

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Low Contrast Agent and Radiation Dose Protocol Liver CT With Deep-learning-based Contrast Boosting Model in Patients at High Risk for HCC: Prospective, Randomized, Single Blinded - Preliminary Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
Jan 25, 2021
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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