Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed: a Pilot Study in the Czech Republic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Hypotesis 1
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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; %).
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; %).
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
- Hypotesis 2(1 year)
- Hypotesis 2_1(1 year)
Investigators
Jan Žatecký
Jan Žatecký, MD, PhD, Principal Investigator
Silesian Hospital in Opava