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Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

RECRUITINGN/ASponsored by Endomagnetics Ltd.
Actively Recruiting
PhaseN/A
SponsorEndomagnetics Ltd.
Started2019-06-13
Est. completion2026-02
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Axillary Lymph NodesBreast CancerCancer

Locations2 sites

Baylor Medicine
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
Veronika NoregilVYNovegil@mdanderson.org

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