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This study is an exploratory study aiming to collect data on sensitivity and positive predictive value of IOP-enhanced (MPB-1523) MRI compared to dynamic multiphase MDCT for the detection of HCC.
The planned duration of the clinical study for individual subjects is up to 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm: IOP injection (MPB-1523) | Experimental | single group treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IOP Injection (MPB-1523) | Drug | one dose, once IV injection at Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Sensitivity and specificity of IOP-enhanced MRI | Sensitivity and specificity of IOP-enhanced MRI will be calculated using dynamic multiphase MDCT as the reference standard. Confirmation of the diagnosis of HCC lesions will be obtained by surgery. | After IOP injection administration within 60 mins |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal time to perform a MRI scan after injection of IOP | Optimal time of IOP Injection | After IOP injection administration within 60 mins |
| The Number of lesions detected in liver | The sensitivity of IOP Injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chien-Hung Chen, MD | National Taiwan University Hospital | Principal Investigator |
| David Wang, MD | MegaPro Biomedical Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Medical Foundation | Kaohsiung City | 833 | Taiwan | |||
| China Medical University Hospital |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| After IOP injection administration within 60 mins |
| The size of lesions detected in liver | The sensitivity of IOP Injection | After IOP injection administration within 60 mins |
| Taichung |
| 404 |
| Taiwan |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |