Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Terumo Medical Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
To investigate the safety and feasibility of a personalized Ho-166-PLLA-MS TARE approach by using MRI guidance in inoperable patients with HCC.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI-guided radioembolization | Experimental | Study patients will receive radioembolization with holmium microspheres in an MRI guided setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI-guided radioembolization | Procedure | Catheter placement will be performed using fluoroscopy, after which patients are transferred to the MRI scanner, where holmium microspheres are administered based on MRI dosimetry. Thereby, patients get a personalized dose administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity profile of dose administration cohorts | Determine a safe maximal healthy liver dose for personalised administration of microspheres based on (S)AEs related to liver toxicity due to radioembolisation. | 12 months after treatment |
| Safety of MRI-guided radioembolization procedure | Monitoring (S)AE's related to the investigated combination of MRI-guided 166Ho radioembolization. | 12 months after treatment |
| Time constraints of performing intraprocedural MRI-based dosimetry | Time constraints for image processing in between administration of microspheres, in order to be able to perform the procedure within half a day. | during treatment procedure |
| Feasibility of performing intraprocedural treatment planning | The ability of deciding on catheter positions and dose aministration during the procedure based on MRI dosimetry by comparing the standard of care treatment plan to the treatment performed during the study. | during treatment procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Dosimetry optimization | Perform optimization of holmium dosimetry using SPECT and MRI | 12 months after treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frank Nijsen, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RadboudUMC | Nijmegen | 6500 HB | Netherlands |
Data is available to other researchers upon reasonable request
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |