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

January 29, 2022 updated by: Jeong Min Lee, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional liver CT
Underwent conventional liver CT on HCC high-risk patient
Radiation: Conventional CT (radiation)
Underwent liver CT without change of radiation.
Drug: Conventional CT (contrast agent)
Underwent liver CT without change of contrast media doses.
Other Names:
  • Standard contrast medium dosage
Experimental: Double low dose CT
Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient
Radiation: Low radiation dose CT
Underwent liver CT with 30% lower radiation dose
Drug: Low contrast dose CT
Underwent liver CT 20% lower dose contrast media.
Other Names:
  • Low contrast medium dosage
Other: Deep-learning based contrast boosting algorithms
Applied deep-learning based contrast boosting algorithms on acquired CT images

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of solid focal lesion in liver
Time Frame: 12 months after last patient's image work up
diagnostic performance
12 months after last patient's image work up
Quantitative image quality analysis
Time Frame: Immediate after study enrollement
Contrast-to-Noise
Immediate after study enrollement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

January 29, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2016-2272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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