Double Low-Dose DECT for HCC Imaging

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HCC

Intervention / Treatment
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* Diagnostic Test: Double Low-Dose protocol CT
* Diagnostic Test: Standard protocol CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double Low-Dose protocol CT<br>Low radiation dose + low amount of iodine contrast media at spectral CT (Philips Healthcare) | Diagnostic Test: Double Low-Dose protocol CT<br>* Double low-dose protocol CT (Low radiation dose quadriphasic liver CT and low dose of iodine contrast media) at spectral dual energy CT scanner<br>|
| Active Comparator: Standard protocol CT<br>Standard protocol quadriphasic liver CT according to current liver CT protocol in our institution, at spectral CT (Philips Healthcare) | Diagnostic Test: Standard protocol CT<br>* standard protocol CT (standard dose quadriphasic liver CT and standard dose of iodine contrast media) at spectral dual energy CT scanner<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT, dual energy, low dose