Using Magseed Pro and Sentimag Gen3 for marking breast and lymph node lesions
Official title: A Prospective, Multi Center, International, Open Label Study of the Use of Magseed Pro(R) Markers and Sentimag(R) Gen3 to Localize Breast Lesions and Suspicious/Biopsy-proven Positive Lymph Nodes in Breast Cancer Patients
Run by Endomagnetics Ltd. · NCT05142787 · Data updated 2026-11-12
This study is testing a new way to mark breast and lymph node lesions to help surgeons find and remove them more accurately during surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 224 (estimated) |
| Sponsor | Endomagnetics Ltd. Industry-sponsored |
| Locations | 6 sites (Bottrop and 5 other locations) |
| Status | Recruiting |
| Started | March 2, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT05142787 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who require localization of breast lesions or axillary lymph nodes for surgical excision.
✕Probably not a fit
Patients who are pregnant, nursing, or have certain medical conditions that may affect their ability to participate will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the safety and effectiveness of the Magseed Pro® marker and Sentimag® Gen3 system for marking suspicious or biopsy-proven positive axillary lymph nodes and soft tissue lesions in the breast. The devices are intended to assist surgeons in accurately locating and excising targeted tissues during surgical procedures. This multicenter international study will involve participants who require localization of breast lesions or axillary nodes prior to surgical excision. Patients will have the Magseed Pro® marker placed to guide the surgical removal of the identified lesions.
Why it matters
Potential benefit: If successful, this approach could enhance the precision of surgical excisions for breast cancer, potentially improving patient outcomes.
How similar studies have gone: Other studies using similar localization techniques have shown promise, indicating that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study * Participant is aged 18 years or older at the time of consent. * Patients requiring breast lesion/axillary node marking and excision Exclusion Criteria:• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. A pregnancy test is required for all women of childbearing potential within 7 days before enrolment. * Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results * Known hypersensitivity to Nitinol * Subject has current active infection at the implantation site in the breast (per investigator discretion)
Where it's running
-
Marienhospital Bottrop GmbH
Bottrop, Germany Recruiting -
AGAPLESION Markus Frankfurter Diakonie Kliniken gGmbH
Frankfurt, Germany Recruiting -
Guy's Hospital
London, United Kingdom Recruiting -
Royal Marsden Hospital
London, United Kingdom Recruiting -
University Hospital South Manchester
Manchester, United Kingdom Recruiting -
Technical University Munich
Munich, Germany Not yet recruiting
Study contacts
- Principal investigator: Stefan Paepke, Dr — The technical university of Munich
- Study coordinator: Matt Womack, Dr
- Email: mwomack@endomag.com
- Phone: +447851247439
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.