CompletedPhase 4

Magseed Magnetic Marker in Locating Axillary Lymph Nodes in Patients With Breast Cancer Undergoing Surgery

United States54 participantsStarted 2017-04-11

Plain-language summary

This phase IV trial studies the side effects of the Magseed magnetic marker and how well it works in locating lymph nodes in the underarm area in patients with breast cancer undergoing surgery. Injecting a small metallic marker in or near the lymph node prior to surgery may help the surgeon locate the lymph nodes during surgery without using radiation.

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: * 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 completing chemotherapy * Received neoadjuvant chemotherapy prior to surgical resection * Scheduled for targeted axillary dissection (defined as selective localization and removal of the clipped node and sentinel lymph node dissection \[SLND\]) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Exclusion Criteria: * Distant metastases * Inflammatory breast cancer * Prior surgical axillary procedure including SLND or axillary node excision * Prior history of breast cancer in the ipsilateral breast * History of lymphoma * The subject is known to be pregnant. Premenopausal patients under the age of 50 must have a pregnancy test performed as standard of care before the MagSeed is placed * Previous radiation to the breast or axilla * Pacemaker of other implantable device in the 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

Timeframe: Up to 15 months

Incidence of adverse events

Timeframe: Up to 6 weeks post-procedure

Trial details

NCT IDNCT03038152

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-01

View on ClinicalTrials.gov More Breast Carcinoma Metastatic in Lymph Node trials