"Double Low-Dose" DECT for HCC Imaging

Not Applicable

Completed

• Conditions: HCC
• Interventions: Diagnostic Test: Standard protocol CT; Diagnostic Test: Double Low-Dose protocol CT

• Registration Number: NCT03045445
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-04
• Study First Submitted QC: 2017-02-04
• Study First Posted: 2017-02-07
• Study Start: 2017-05-30
• Primary Completion: 2018-03-21
• Study Completion: 2019-09-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard protocol CT	Standard protocol CT	Standard protocol quadriphasic liver CT according to current liver CT protocol in our institution, at spectral CT (Philips Healthcare)
Double Low-Dose protocol CT	Double Low-Dose protocol CT	Low radiation dose + low amount of iodine contrast media at spectral CT (Philips Healthcare)

Primary Outcome Measures

Name	Time	Method
Lesion conspicuity	12 months after CT	qualitative conspicuity assessment of focal liver lesion

Secondary Outcome Measures

Name	Time	Method
beam hardening artifact	12 months after CT	qualitative analysis
hepatic artery conspicuity	12 months after CT	qualitative analysis
image texture (plasticity)	12 months after CT	qualitative analysis
sensitivity to detect HCC	18 months after CT	according to LI-RADS
image noise	12 months after CT	qualitative analysis
radiation dose	1 month after CT	CTDIvol, DLP, and effective dose
portal vein conspicuity	12 months after CT	qualitative analysis
overall image quality	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of