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| Name | Class |
|---|---|
| Guerbet | INDUSTRY |
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This study aims to investigate the clinical feasibility of abbreviated liver MRI for HCC surveillance in a high-risk group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High risk group of HCC | Experimental | High risk group of HCC with chronic hepatitis or liver cirrhosis. Participants undergo biannual ultrasonography and annual abbreviated liver MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biannual ultrasonography | Diagnostic Test | Biannual liver ultrasonography for HCC surveillance, without contrast agent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity for detecting HCC | Sensitivity for detecting HCC | 12 months after last MRI |
| Measure | Description | Time Frame |
|---|---|---|
| Table time of abbreviated MRI | time from scan start and scan end | 1 day after each MRI |
| In-room time of abbreviated MRI | interval between participants' walk-in and walk-out times |
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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 | ||||
| The Catholic University of Korea, Seoul St. Mary's Hospital |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008103 | Liver Cirrhosis |
| D006521 | Hepatitis, Chronic |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Annual abbreviated liver MRI | Diagnostic Test | Abbreviated liver MRI using standard dose of extracellular contrast agent (Dotarem, Guerbet, France) on weight-based dosing. Table time targets 10 minutes. |
|
|
| 1 day after each MRI |
| Specificity for detecting HCC | Specificity for detecting HCC | 12 months after last MRI |
| Sensitivity for detecting early stage HCC | Sensitivity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor) | 12 months after last MRI |
| Specificity for detecting early stage HCC | Specificity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor) | 12 months after last MRI |
| Image quality of abbreviated liver MRI | qualitative analysis on four-point scale | 12 months after last MRI |
| Seoul |
| South Korea |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006505 | Hepatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |