RecruitingNot ApplicableNCT03796559

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


Sponsor

Endomagnetics Ltd.

Enrollment

65 participants

Start Date

Jun 13, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a tiny magnetic seed (called Magseed) can be placed into a lymph node in the armpit before chemotherapy in breast cancer patients, allowing surgeons to accurately find and remove the exact lymph node months later after treatment is complete. This technique may allow for less extensive surgery. **You may be eligible if...** - You are 18 years or older - You have breast cancer with confirmed spread to an armpit lymph node (verified by needle biopsy) - A small metal clip has been placed in that lymph node before you start chemotherapy - You are planned to receive chemotherapy before surgery (neoadjuvant chemotherapy) - You are a candidate for targeted axillary surgery (removing fewer lymph nodes) **You may NOT be eligible if...** - Your lymph node involvement has not been confirmed by biopsy - You are not receiving chemotherapy before surgery - You have conditions that prevent safe use of the magnetic seed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMagseed Marker

Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.


Locations(2)

Baylor Medicine

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

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NCT03796559


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