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Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed

ConditionBreast Cancer Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorJan Žatecký

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

disagree with participation in the study

Trial population

Patients with non-palpable breast cancer or pathological lymph node localised by magnetic seed Sirius Pintuition.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jan Žatecký

Lead sponsor

Silesian Hospital in Opava

Sponsor institution

Source ClinicalTrials.gov
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