RecruitingNot Applicable

Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

United States65 participantsStarted 2019-06-13

Plain-language summary

The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following neo-adjuvant chemotherapy (NAC) is effective.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older at time of consent * Histologically confirmed cT0-4, N1 breast cancer * Axillary lymph node metastasis with pathologic confirmation by needle biopsy * Clip placed in the sampled axillary lymph node before initiation of chemotherapy * Planned for neo-adjuvant chemotherapy prior to surgical resection * Eligible for targeted axillary dissection (defined as selective localization and removal of the clipped node and SLND) at the completion of neo-adjuvant chemotherapy * ECOG performance status 0-2 Exclusion Criteria: * Distant metastases * Inflammatory breast cancer * Prior ipsilateral axillary surgical procedure including SLND or axillary node excision * Prior history of breast cancer in the ipsilateral breast * History of lymphoma * Subject is pregnant * Previous radiation to the breast or axilla * Pacemaker or other implantable cardiac device in the ipsilateral chest wall

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Retrieval rate of clipped node and Magseed in the excised specimen

Timeframe: Time of surgery

Trial details

NCT IDNCT03796559

SponsorEndomagnetics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02

Contact for this trial

Matt Womack, PhD

+447851247439 mwomack@endomag.com

View on ClinicalTrials.gov More Breast Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.