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A prospective pilot study in the Czech Republic examining the use of magnetic seed Sirius Pintuition for the localization of non-palpable malignant breast tumors and pathological lymph nodes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast cancer localisation with magnetic seed Sirius Pintuition | Device | Patients with histologically proven non-palpable breast cancer or with histologically proven pathological lymph node will be localised by a magnetic seed Sirius Pintuition. |
| Measure | Description | Time Frame |
|---|---|---|
| Hypotesis 1 | Localization of non-palpable breast tumors and pathological lymph nodes with a magnetic seed Sirius Pintuition is comparable to other localization methods (iodine seed, wire-guided localisation) in the incidence of complications during intraoperative marker detection (absolute and relative incidence; %). | 1 year |
| Hypotesis 1_1 | Localization of non-palpable breast tumors and pathological lymph nodes with a magnetic seed Sirius Pintuition is comparable to other localization methods (iodine seed, wire-guided localisation) in the incidence of complications during marker insertion (absolute and relative incidence; %). | 1 year |
| Hypotesis 1_2 | Localization of non-palpable breast tumors and pathological lymph nodes with a magnetic seed Sirius Pintuition is comparable to other localization methods (iodine seed, wire-guided localisation) in the incidence seed migration (absolute and relative incidence, %). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Hypotesis 2 | Localization of non-palpable breast tumors with a magnetic seed Sirius Pintuition is more accurate in terms of more frequent achievement of R0 resection while preserving the oncological radicality (absolute and relative incidence; %). | 1 year |
| Hypotesis 2_1 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with non-palpable breast cancer or pathological lymph node localised by magnetic seed Sirius Pintuition.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Žatecký | Contact | +420553766111 | janzatecky.jz@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silesian Hospital in Opava | Recruiting | Opava | 74601 | Czechia |
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Localization of non-palpable breast tumors with a magnetic seed Sirius Pintuition is more accurate in removing smaller tissue volume while preserving the oncological radicality (volume, cm3). |
| 1 year |