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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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The goal of this multicentre clinical pilot study is to investigate the feasibility of the addition of Ho-166 radioembolization to chemotherapy in patients with liver metastastic breast cancer.
Participants will receive a mapping angiography and Ho-166 radioembolization. Chemotherapy will be stopped 2-5 prior to radioembolization and continuation of chemotherapy will be evaluated at 2 weeks post-radioembolization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ho-166 radioembolization | Experimental | Patients will undergo standard procedures for holmium radioembolization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quiremspheres™ | Device | The intervention comprises two steps. Initially, the patient will undergo mapping angiography and a Ho-166 scout dose. If deemed eligible, the patient will proceed to 166-Ho radioembolization. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | The percentage of patients were radioembolization and systemic chemotherapy is safely feasible. Safety is defined as percentage of 90 day post-radioembolization (CTCAE/SIR grade 3 or higher) which lead discontinuation of the current systemic chemotherapy. Time to re-start chemotherapy after intervention in days will be collected. | Up to 3 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion- and patient-based response | Radiological response on contrast-enhanced CT and MRI measured by RECIST | Up to 3 months after intervention |
| Overall toxicity associated with study intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth G Klompenhouwer, MD, PhD | Contact | +31205129111 | holibreast@nki.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leuven | Not yet recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
Graded by CTCAE/SIR grade
| Up to 3 months after intervention |
| Quality of Life during study | Obtained by EORTC QLQ-C30 questionnaire | From start inclusion to 3 months after intervention |
| Netherlands Cancer Institute | Recruiting | Amsterdam | North Holland | 1066 CX | Netherlands |
|
| D017437 |
| Skin and Connective Tissue Diseases |