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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03045445

Enrollment

Registered

2017-02-07

Start date

2017-05-30

Completion date

2019-09-25

Last updated

2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC

Keywords

CT, dual energy, low dose

Brief summary

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.

Interventions

DIAGNOSTIC_TESTDouble 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

DIAGNOSTIC_TESTStandard protocol CT

standard protocol CT (standard dose quadriphasic liver CT and standard dose of iodine contrast media) at spectral dual energy CT scanner

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026