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The primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled.
The primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled. Primary endpoint : Local response (evaluated with CT and MRI at 4 to 6 weeks post each procedure and at 6 months according to mRECIST) in patients with intermediate-stage HCC following chemoembolisation with radiopaque bead. Secondary endpoints include: 1) Better definition of end point of embolization for drug eluting beads : Ability to achieve near-stasis during chemoembolisation procedure in the tumour feeding vessels using intra-procedural imaging feedback from the radiopaque bead (early visualization of non target embolization 2) Total dose needed for tumor devascularization 3)Distribution of radiopaque beads and correlation with necrosis and adverse events
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemoembolization | Device | correlation of necrosis with the deposition of beads |
| Measure | Description | Time Frame |
|---|---|---|
| CORRELATION OF LUMI DISTRIBUTION WITH NECROSIS | Local response following chemoembolisation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Definition of end point of embolization for drug eluting beads | optimization of embolization | 12 months |
| Total dose needed for tumor devascularization | dose required for tumor devascularization |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with intermediate stage hepatocellular carcinoma (BCLC B)
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| Name | Affiliation | Role |
|---|---|---|
| KATERINA MALAGARI | Evgenidion Hospital Athens, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evgenidion Hospital | Athens | Attica | 15538 | Greece |
CT and MRI images will be stored anonymously by giving each patient a code number
starting February 2018 and ending February 2019
the principal investigator and collaborator will record and analyse data from the CT and MRI of the patients. The names of the patients will not be in the examinations and identity will be given by enrollment number
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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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| ID | Term |
|---|---|
| D016461 | Chemoembolization, Therapeutic |
| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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| 12 months |
| Distribution of radiopaque beads and correlation with necrosis | correlation between imaging and tumor necrosis | 12 months |
| D008107 |
| Liver Diseases |