Using Magseed Pro and Sentimag Gen3 for marking breast and lymph node lesions
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Endomagnetics Ltd. Industry-sponsored |
| Locations | 6 sites (Bottrop and 5 other locations) |
| Trial ID | NCT05142787 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require localization of breast lesions or axillary lymph nodes for surgical excision.
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.
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 performed: Other studies using similar localization techniques have shown promise, indicating that this approach may be effective.
Eligibility criteria
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 this trial is running
Bottrop and 5 other locations
- Marienhospital Bottrop GmbH — Bottrop, Germany (Recruiting)
- AGAPLESION Markus Frankfurter Diakonie Kliniken gGmbH — Frankfurt, Germany (Recruiting)
- Technical University Munich — Munich, Germany (Not_yet_recruiting)
- Guy's Hospital — London, United Kingdom (Recruiting)
- Royal Marsden Hospital — London, United Kingdom (Recruiting)
- University Hospital South Manchester — Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Stefan Paepke, Dr — The technical university of Munich
- Study coordinator: Matt Womack, Dr
- Email: mwomack@endomag.com
- Phone: +447851247439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.