Breast Cancer Surgery
Conditions
Brief summary
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.
Interventions
DEVICEBreast cancer localisation with magnetic seed Sirius Pintuition
Patients with histologically proven non-palpable breast cancer or with histologically proven pathological lymph node will be localised by a magnetic seed Sirius Pintuition.
Sponsors
Jan Žatecký
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* breast cancer confirmed by a core-cut biopsy * localisation of non-palpable breast cancer or pathological lymph node with a magnetic seed Sirius Pintuition * breast cancer surgery in Surgical dpt, Silesian Hospital in Opava
Exclusion criteria
* disagree with participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypotesis 1 | 1 year | 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; %). |
| Hypotesis 1_1 | 1 year | 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; %). |
| Hypotesis 1_2 | 1 year | 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, %). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypotesis 2 | 1 year | 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; %). |
| Hypotesis 2_1 | 1 year | 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). |
Countries
Czechia
Contacts
Primary ContactJan Žatecký
Outcome results
None listed