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| Name | Class |
|---|---|
| Siemens Corporation, Corporate Technology | INDUSTRY |
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This study aims to assess whether the acceptable image quality is achievable using low monoenergetic imaging of dual-energy CT with deep learning-based denoising, and low contrast media dose calculated based on lean body weight for the detection of hepatocellular carcinoma.
The use of iodinated contrast media in CT is associated with an immediate hypersensitivity reaction in a dose-dependent manner. Therefore, it is important to reduce the contrast dose for CT exams in patients who are required repeated CT examinations, including patients with hepatocellular carcinoma (HCC). Low monoenergetic images of dual-energy CT can provide higher iodine contrast than conventional images, thus enabling reduction of contrast media. The high image noise in low monoenergetic images may be improved by using model-based IR techniques and deep learning-based denoising (DLD) algorithms. Besides, lean body weight (LBW)-based contrast dose determination can be another option to reduce contrast media dose compared with total body weight-based dose determination since the volumes of blood and liver are not strictly proportional to total body weight. Therefore, we surmised that 50 keV images reconstructed with DLD algorithms with reducing iodine load by 30% based on LBW could produce the comparable image quality and lesion conspicuity compared with standard iodine-dose 120kVp images.
In this single-center prospective, randomized clinical trial, we aimed to investigate the effectiveness of low-contrast dose CT using 50 keV and DLD technique compared with the standard contrast-dose protocol using model-based IR in patients at high risk of HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 keV DLD images of the LBW-based low-dose group | Experimental | Low CT contrast media dose calculated based on lean body weight and low monoenergetic images of dual-energy CT with deep learning-based denoising |
|
| ADMIRE images of the standard-contrast dose group | Active Comparator | Standard CT contrast media dose calculated based on total body weight and conventional images with full model-based iterative reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low dose CT contrast media - lean body weight | Other | CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 450mgI/kg based on lean body weight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HCC conspicuity | qualitative scoring for focal lesion depiction on four-point scale (1: worst, 4: excellent, representative value is average score) | 6 months after complete enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Image noise | qualitative scoring for image noise on four-point scale (1: worst, 4: excellent, representative value is average score) | 12 months after complete enrollment |
| Image contrast | qualitative scoring for image contrast on four-point scale (1: worst, 4: excellent, representative value is average score) |
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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 |
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| Standard dose CT contrast media | Other | CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 560mgI/kg based on total body weight. |
|
| 12 months after complete enrollment |
| Overall image quality | qualitative scoring for image quality on four-point scale (1: worst, 4: excellent, representative value is average score) | 6 months after complete enrollment |
| Lesion detection | assessment of focal liver lesion (HCC) on CT according to Liver Imaging Reporting and Data System (LI-RADS) | 12 months after complete enrollment |
| Hounsfield unit | measurement of hounsfield unit in aorta, portal vein, liver parenchyma, and paraspinal muscles | 3 months after complete enrollment |
| Contrast media dose | administered contrast media dose in each group | 3 months after complete enrollment |
| Radiation dose | measured radiation dose in each group | 3 months after complete enrollment |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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