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Subjects with large inoperable liver tumors defined as at least 1 lesion larger than 5cm in maximum diameter. For the purposes of the present study, we define the AMARA principle in intensified regional TARE as a planned irradiated tumor dose >200Gy by the partition model. The purpose of the study is to evaluate the safety and efficacy of Y90 high dose radioembolization for the management of large inoperable liver tumors. In addition, to correlate the safety and efficacy with the post-treatment dosimetry analysis (by MIM Software Inc) based on 90Y-PET/CT imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TARE group | (TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transarterial Radioembolization | Device | (TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Adverse Events related with the procedure | 6 months |
| LPFS | Liver Progression Free Survival after the procedure | 2 years |
| Tumor Response | Complete Response will be measured with the LI-RADS criteria for treatment response (LR-TR). In addition, RECIST v1.1, mRECIST, and PET-RECIST criteria will be further evaluated. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Post-treatment dosimetry analysis | Correlate the safety and efficacy with the post-treatment dosimetry analysis | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals presenting with either primary or metastatic hepatic malignancies are the study population.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Konstantinos Katsanos, Professor | Contact | +306978225019 | katsanos@med.upatras.gr |
| Name | Affiliation | Role |
|---|---|---|
| Platon Dimopoulos, Resident | University Hospital of Patras | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Patras | Recruiting | Pátrai | Achaia | 26500 | Greece |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| D008107 |
| Liver Diseases |