"Double Low-Dose" DECT for HCC Imaging

Seoul National University

Status: Completed

Conditions: HCC

Treatments: Diagnostic Test: Standard protocol CT; Diagnostic Test: Double Low-Dose protocol CT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03045445

SNUH-2016-2830

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups

Double Low-Dose protocol CT

Experimental group

Description:

Low radiation dose + low amount of iodine contrast media at spectral CT (Philips Healthcare)

Treatment:

Diagnostic Test: Double Low-Dose protocol CT

Standard protocol CT

Active Comparator group

Description:

Standard protocol quadriphasic liver CT according to current liver CT protocol in our institution, at spectral CT (Philips Healthcare)

Treatment:

Diagnostic Test: Standard protocol CT