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NCT Number: NCT06799858

Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed

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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Key information

Conditions

Breast Cancer Surgery

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Hypotesis 1

    Time frame: 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; %).

  2. Hypotesis 1_1

    Time frame: 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; %).

  3. Hypotesis 1_2

    Time frame: 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 outcomes

  1. Hypotesis 2

    Time frame: 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; %).

  2. Hypotesis 2_1

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Žatecký

CONTACT

[email protected]

+420553766111

Sponsors and collaborators

Lead sponsor

Jan Žatecký

Other

Registry information

Official study title

Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed: a Pilot Study in the Czech Republic

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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