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| Name | Class |
|---|---|
| Terumo Medical Corporation | INDUSTRY |
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To investigate the in vivo performance and safety of a novel medical device for the injection of holmium-166 microspheres during radioembolization. The main potential advantage of this device is that it allows for injection of a during treatment determined dose, which is not possible with the current administration tool.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study patients | Experimental | study patients will receive holmium radioembolization using a novel administration device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional administration device | Device | The novel fractional administration device enable the administration of the microspheres in fractions determined by the user. For this study, 5 fractions of 20% will be administered and validated using MRI. |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of a fractional administration device for holmium radioembolization | The device will be valid if the administered fractions can be quantified on MRI with a maximal deviation of 15%. | 3 months after treatment |
| Safety of a fractional administration device for holmium radioembolization | The safety of the device will be determined by monitoring the (S)AE's and (S)ADE's | 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Accurate dosimetry based on MRI and SPECT imaging of holmium-166. | To perform dosimetry based on MRI and SPECT imaging of holmium-166 and correlate this to tumour response | 6 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Nijsen, PhD. | Associate professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RadboudUMC | Nijmegen | Netherlands |
Participant data will be available upon reasonable request
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |