Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed

NCT06799858 | Recruiting

• 1 other identifier: EK SNO 429/2024
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Surgery

Outcome Measures

Primary Outcomes (3)

• 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; %).

  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; %).

  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, %).

  1 year

Secondary Outcomes (2)

• Hypotesis 2

  1 year

• Hypotesis 2_1

  1 year

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• disagree with participation in the study

Sponsors & Collaborators

• Jan Žatecký: lead

Study Sites (1)

Silesian Hospital in Opava

Opava, 74601, Czechia

RECRUITING

Central Study Contacts

Jan Žatecký

CONTACT

+420553766111; [email protected]

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Jan Žatecký, MD, PhD, Principal Investigator

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 29, 2025
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

CZ (1)