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| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double Low-Dose protocol CT | Experimental | Low radiation dose + low amount of iodine contrast media at spectral CT (Philips Healthcare) |
|
| Standard protocol CT | Active Comparator | Standard protocol quadriphasic liver CT according to current liver CT protocol in our institution, at spectral CT (Philips Healthcare) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double Low-Dose protocol CT | Diagnostic Test | Double low-dose protocol CT (Low radiation dose quadriphasic liver CT and low dose of iodine contrast media) at spectral dual energy CT scanner |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion conspicuity | qualitative conspicuity assessment of focal liver lesion | 12 months after CT |
| Measure | Description | Time Frame |
|---|---|---|
| image noise | qualitative analysis | 12 months after CT |
| beam hardening artifact | qualitative analysis | 12 months after CT |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31917765 | Derived | 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. |
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| Standard protocol CT | Diagnostic Test | standard protocol CT (standard dose quadriphasic liver CT and standard dose of iodine contrast media) at spectral dual energy CT scanner |
|
| 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 |
| 1 month after CT |
| Enhancement degree | HU in aorta, portal vein and liver parenchyma on each phase of CT | 12 months after CT |