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Magseed for Axillary Lymph Node Localization in Breast Cancer

This study is testing a device called Magseed to help doctors find and remove lymph nodes in your armpit (axillary lymph nodes) that have breast cancer. If you have breast cancer that has spread to your armpit lymph nodes and a clip was placed in one of these nodes before chemotherapy, you might be able to join. The Magseed will be placed in the affected lymph node before you start chemotherapy. After chemotherapy, during surgery, the Magseed will help your surgeon locate and remove that specific lymph node. The main goal is to see how often the Magseed and the clipped lymph node are successfully removed together during surgery. The current status of this study is unclear, and it plans to enroll 65 participants.

Study design
This is a single-arm study, meaning all participants receive the same intervention. It is open-label, so both you and your doctors will know you are receiving the Magseed. The study plans to enroll 65 participants.
What's involved
You would have the Magseed placed in an axillary lymph node before starting chemotherapy. After chemotherapy, the Magseed would be localized and removed during your planned surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at the time of surgery. No further follow-up is specified.

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NCT03796559

Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

Recruiting
NAAges 18+InterventionalTreatment
Endomagnetics Ltd.
~65 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:Magseed Marker

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Retrieval rate of clipped node and Magseed in the excised specimen
Measured over Time of surgery

Conditions

Breast Cancer
Axillary Lymph Nodes

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Abigail Caudle, MD, MS · PRINCIPAL_INVESTIGATOR · MD Anderson Cancer Center, Houston, TX

Who to contact

Matt Womack, PhD
[email protected]
+447851247439
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Retrieval rate of clipped node and Magseed in the excised specimenTime of surgery

    The retrieval rate of the clipped node and Magseed in the excised specimen. This is defined as the number of subjects in whom the clipped node and Magseed are retrieved in a single excised specimen divided by the total number of subjects.