Breast Cancer SurgeryNCT06799858
Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed
An observational study of Breast Cancer Surgery, run by Jan Žatecký at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer Surgery
- What is being tested?
- Breast cancer localisation with magnetic seed Sirius Pintuition
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-palpable breast cancer or pathological lymph node localised by magnetic seed Sirius Pintuition.
Who may be able to join
- 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
Who cannot join
- disagree with participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Silesian Hospital in Opava
Opava, 74601
Jan Žatecký, +420553766111, janzatecky.jz@gmail.com
About this study
Official title: Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed: a Pilot Study in the Czech Republic
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
- Being tested
- Breast cancer localisation with magnetic seed Sirius Pintuition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast cancer localisation with magnetic seed Sirius PintuitionDevice
Patients with histologically proven non-palpable breast cancer or with histologically proven pathological lymph node will be localised by a magnetic seed Sirius Pintuition.
What is being measured
The primary outcome is the main question the study is designed to answer.
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; %).
Measured: 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; %).
Measured: 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, %).
Measured: 1 year
Secondary outcomes (2)
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; %).
Measured: 1 year
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Apr 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jan Žatecký
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jan Žatecký, Silesian Hospital in Opava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799858
- Sponsor's protocol ID
- EK SNO 429/2024
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed: a Pilot Study in the Czech Republic
- ClinicalTrials.gov ID
- NCT06799858
- Acronym / sponsor ID
- EK SNO 429/2024
- Conditions
- Breast Cancer Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jan ŽateckýUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-palpable breast cancer or pathological lymph node localised by magnetic seed Sirius Pintuition.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- disagree with participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast cancer localisation with magnetic seed Sirius PintuitionPatients with histologically proven non-palpable breast cancer or with histologically proven pathological lymph node will be localised by a magnetic seed Sirius Pintuition. | Device | – |
Primary outcome
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, %).
2 secondary outcomes
Hypotesis 2
Time frame: 1 year
Hypotesis 2_1
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
Related trials for Breast Cancer Surgery
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
Recruiting
Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery
Breast Cancer
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
Triple-Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Surgery, run by Jan Žatecký at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Žatecký (+420553766111, janzatecky.jz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypotesis 1 (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.