Using Magseed to locate axillary lymph nodes in breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of the Magseed and Sentimag systems in marking and surgically localizing axillary lymph nodes in breast cancer patients who have undergone neo-adjuvant chemotherapy. Participants will have a Magseed marker placed in their axillary lymph nodes before starting chemotherapy, and after treatment, the nodes will be localized and removed during surgery. The study is designed as a post-market, prospective, open-label, single-arm trial, focusing on patients with biopsy-proven axillary node metastases. The goal is to provide evidence for the effectiveness of this technique in improving surgical outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Baylor Medicine
  Houston, Texas, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Abigail Caudle, MD, MS — MD Anderson Cancer Center, Houston, TX
• Study coordinator: Matt Womack, PhD
• Email: mwomack@endomag.com
• Phone: +447851247439

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.