Evaluation of Magseed as Localization Device for Biopsy Proven Metastatic Axillary Lymph Nodes

Stopped early · Not applicable

Conditions studied: Breast Cancer

In brief

Currently, breast cancer patients who are treated with neoadjuvant chemotherapy (NAC) before surgery may have a biopsy clip placed in the lymph node at the time of or shortly after percutaneous biopsy. Following 12-20+ weeks of NAC, pre-surgical localization of the sampled axillary lymph node using a radioactive seed can be done up to 5 days prior to surgery. Localization of the sampled lymph node in patients with complete imaging response to NAC can be technically challenging if the biopsy clip is not sonographically visible. This study is designed to see if it is feasible to place a Magseed, which is magnetic seed, into the abnormal node either at the time of fine needle aspiration (FNA) or after NAC, just prior to surgery, and to be able to accurately identify the abnormal node at the time of surgery.

Key facts

Study ID

NCT03718455

Run by

Mayo Clinic

People needed

1

Starts

2018-10-30

Expected to finish

2019-12-01

Last updated by the study team

2020-10-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women 18 years or older
• Neoadjuvant chemotherapy planned prior to surgical excision
• Scheduled for target axillary lymph node dissection including the localized lymph node and sentinel lymph node

You may not qualify if…

• Pregnant or nursing women
• Allergy to lidocaine or gadolinium
• Contraindication to MRI (i.e. pacemaker)
• Axillary Infection
• Prior axillary radiation
• Known allergy to bone wax, beeswax or propolis

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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