Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed

NCT ID: NCT06799858

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Breast 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jan Žatecký

OTHER

Sponsor Role lead

Responsible Party

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Jan Žatecký

Jan Žatecký, MD, PhD, Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Silesian Hospital in Opava

Opava, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Jan Žatecký

Role: CONTACT

+420553766111

Facility Contacts

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Jan Žatecký

Role: primary

+420553766111

Other Identifiers

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EK SNO 429/2024

Identifier Type: -

Identifier Source: org_study_id

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