search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Low radiation dose CT
Conventional CT (radiation)
Low contrast dose CT
Conventional CT (contrast agent)
Deep-learning based contrast boosting algorithms
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring CT

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional liver CT

Double low dose CT

Arm Description

Underwent conventional liver CT on HCC high-risk patient

Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient

Outcomes

Primary Outcome Measures

Detection rate of solid focal lesion in liver
diagnostic performance
Quantitative image quality analysis
Contrast-to-Noise

Secondary Outcome Measures

Full Information

First Posted
September 8, 2016
Last Updated
January 29, 2022
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04722120
Brief Title
Low Contrast Agent and Radiation Dose Protocol for Liver CT in Patients With HCC
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Participants, investigators, and outcome assessors were all masked to the allocation
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional liver CT
Arm Type
Active Comparator
Arm Description
Underwent conventional liver CT on HCC high-risk patient
Arm Title
Double low dose CT
Arm Type
Experimental
Arm Description
Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient
Intervention Type
Radiation
Intervention Name(s)
Low radiation dose CT
Intervention Description
Underwent liver CT with 30% lower radiation dose
Intervention Type
Radiation
Intervention Name(s)
Conventional CT (radiation)
Intervention Description
Underwent liver CT without change of radiation.
Intervention Type
Drug
Intervention Name(s)
Low contrast dose CT
Other Intervention Name(s)
Low contrast medium dosage
Intervention Description
Underwent liver CT 20% lower dose contrast media.
Intervention Type
Drug
Intervention Name(s)
Conventional CT (contrast agent)
Other Intervention Name(s)
Standard contrast medium dosage
Intervention Description
Underwent liver CT without change of contrast media doses.
Intervention Type
Other
Intervention Name(s)
Deep-learning based contrast boosting algorithms
Intervention Description
Applied deep-learning based contrast boosting algorithms on acquired CT images
Primary Outcome Measure Information:
Title
Detection rate of solid focal lesion in liver
Description
diagnostic performance
Time Frame
12 months after last patient's image work up
Title
Quantitative image quality analysis
Description
Contrast-to-Noise
Time Frame
Immediate after study enrollement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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 Agent and Radiation Dose Protocol for Liver CT in Patients With HCC

We'll reach out to this number within 24 hrs