An observational study in Breast Cancer Surgery, sponsored by Jan Žatecký. Recruiting at 1 site in Czech Republic. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Jan Žatecký · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 40 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Jan Žatecký as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients with non-palpable breast cancer or pathological lymph node localised by magnetic seed Sirius Pintuition.
Exclusion Criteria:
Patients with histologically proven non-palpable breast cancer or with histologically proven pathological lymph node will be localised by a magnetic seed Sirius Pintuition.
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; %).
Time frame: 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; %).
Time frame: 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, %).
Time frame: 1 year
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; %).
Time frame: 1 year
Hypotesis 2_1
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).
Time frame: 1 year
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