"Double Low-Dose" DECT for HCC Imaging

Comparison of Image Quality Between "Double Low-Dose" Dual Energy Liver CT and Standard Contrast Enhanced Liver CT in Patients at High-risk of HCC: Prospective, Randomized Single Center Study

Hypothesis: double low-dose protocol provide better lesion conspicuity than standard protocol CT in patients at high-risk of HCC.

patients who are scheduled for CECT for HCC diagnosis or surveillance are eligible for this study and allocated to either standard protocol or double-low dose protocol using spectral CT with low radiation dose and low dose of contrast media, within clinically accpetable range.

Study Overview

• Status: Completed
• Conditions: HCC
• Intervention / Treatment: Diagnostic test: Double Low-Dose protocol CT; Diagnostic test: Standard protocol CT

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• high risk of HCC (chronic hepatitis B or C, or LC of any cause)
• signed informed consent
• scheduled for contrast enhanced liver CT for HCC surveillance or diagnosis

Exclusion Criteria:

• no risk factor for HCC
• history of iodine hypersensitivity
• renal dysfunction (Estimated GFR < 30mL/min/1.73m2) or on dialysis
• metformin medication within 48 hours
• any other contraindication of CE-CT
• BMI > or = 30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Double Low-Dose protocol CT; Low radiation dose + low amount of iodine contrast media at spectral CT (Philips Healthcare)	Diagnostic test: Double Low-Dose protocol CT; Double low-dose protocol CT (Low radiation dose quadriphasic liver CT and low dose of iodine contrast media) at spectral dual energy CT scanner
ACTIVE_COMPARATOR: Standard protocol CT; Standard protocol quadriphasic liver CT according to current liver CT protocol in our institution, at spectral CT (Philips Healthcare)	Diagnostic test: Standard protocol CT; standard protocol CT (standard dose quadriphasic liver CT and standard dose of iodine contrast media) at spectral dual energy CT scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion conspicuity	qualitative conspicuity assessment of focal liver lesion	12 months after CT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
image noise	qualitative analysis	12 months after CT
beam hardening artifact	qualitative analysis	12 months after CT
hepatic artery conspicuity	qualitative analysis	12 months after CT
portal vein conspicuity	qualitative analysis	12 months after CT
image texture (plasticity)	qualitative analysis	12 months after CT
overall image quality	qualitative analysis	12 months after CT
presence of hepatic artery anatomic variation	yes, no, indeterminate and if yes) describe the variation	12 months after CT
sensitivity to detect HCC	according to LI-RADS	18 months after CT
radiation dose	CTDIvol, DLP, and effective dose	1 month after CT

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
contrast media iodine amount	contrast media iodine amount	1 month after CT
adverse effect	any adverse effect related with contrast media	1 month after CT
Enhancement degree	HU in aorta, portal vein and liver parenchyma on each phase of CT	12 months after CT

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Philips Healthcare

Publications and helpful links

General Publications

• Yoon JH, Chang W, Lee ES, Lee SM, Lee JM. Double Low-Dose Dual-Energy Liver CT in Patients at High-Risk of HCC: A Prospective, Randomized, Single-Center Study. Invest Radiol. 2020 Jun;55(6):340-348. doi: 10.1097/RLI.0000000000000643.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2017
• Primary Completion (ACTUAL): March 21, 2018
• Study Completion (ACTUAL): September 25, 2019

Study Registration Dates

• First Submitted: February 4, 2017
• First Submitted That Met QC Criteria: February 4, 2017
• First Posted (ESTIMATE): February 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: CT; low dose; dual energy
• Other Study ID Numbers: SNUH-2016-2830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No