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Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

A Prospective Open Label Study of the Use of Magseed® Markers and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-proven Metastases in Breast Cancer Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies, Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed to mark the metastatic node and are having that clipped node selectively removed at surgery following neo-adjuvant chemotherapy (NAC)."
  • "Subjects will have the Magseed placed to mark axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before initiating NAC."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well Magseed/Sentimag marks lymph nodes in the armpit and helps surgeons find them after chemotherapy. It is for adults with breast cancer that has spread to armpit lymph nodes who plan to have chemotherapy before surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older when you agree to join.
  • Have breast cancer confirmed by a tissue test, classified as cT0–4, N1.
  • Have cancer in an armpit lymph node confirmed by a needle biopsy, which removes a small tissue sample.
  • Have a clip placed in the sampled armpit lymph node before chemotherapy starts.
  • Plan to have chemotherapy before surgery to remove the cancer.
  • Be able to have the clipped lymph node and sentinel nodes removed after chemotherapy. Sentinel nodes are the first nodes cancer may spread to.
  • Have an ECOG activity score of 0–2: be able to care for yourself and be out of bed or a chair for more than half the day.

Who can't join

  • Cancer has spread to distant parts of the body.
  • Have inflammatory breast cancer.
  • Had surgery on armpit lymph nodes on the same side as the breast cancer, including removal of sentinel nodes or other lymph nodes.
  • Had breast cancer before in the same breast.
  • Have a history of lymphoma, a cancer of the lymph system.
  • Are pregnant.
  • Had radiation treatment to the breast or armpit.
  • Have a pacemaker or another implanted heart device in the chest wall on the same side as the breast cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

TX