Magseed Magnetic Marker in Locating Axillary Lymph Nodes in Patients With Breast Cancer Undergoing Surgery

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 4

Conditions: Breast Carcinoma Metastatic in Lymph Node; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7

Treatments: Procedure: Axillary Lymph Node Dissection; Device: Medical Device; Procedure: Localization

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03038152

NCI-2017-00649 (Registry Identifier)

2016-0806 (Other Identifier)

Details and patient eligibility

About

This phase IV trial studies the side effects of the Magseed magnetic marker and how well it works in locating lymph nodes in the underarm area in patients with breast cancer undergoing surgery. Injecting a small metallic marker in or near the lymph node prior to surgery may help the surgeon locate the lymph nodes during surgery without using radiation.

Full description

PRIMARY OBJECTIVE:

I. To provide evidence that the clipped lymph node and Magseed can be successfully retrieved in the excised surgical specimen when Magseed and Sentimag are used for targeted axillary dissection in breast cancer patients.

OUTLINE:

Patients receive the Magseed marker via ultrasound guided injection into the previously clipped lymph node or within perinodal tissue =< 3 mm from the clipped node. Patients then undergo axillary lymph node localization and targeted dissection within 30 days.

After completion of study, patients are followed up within 6-22 days post-surgery.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 completing chemotherapy
• Received neoadjuvant chemotherapy prior to surgical resection
• Scheduled for targeted axillary dissection (defined as selective localization and removal of the clipped node and sentinel lymph node dissection [SLND])
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion criteria

• Distant metastases
• Inflammatory breast cancer
• Prior surgical axillary procedure including SLND or axillary node excision
• Prior history of breast cancer in the ipsilateral breast
• History of lymphoma
• The subject is known to be pregnant. Premenopausal patients under the age of 50 must have a pregnancy test performed as standard of care before the MagSeed is placed
• Previous radiation to the breast or axilla
• Pacemaker of other implantable device in the chest wall

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Diagnostic (Magseed marker)

Experimental group

Description:

Patients receive the Magseed marker via ultrasound guided injection into the previously clipped lymph node or within perinodal tissue =\< 3mm from the clipped node. Patients then undergo axillary lymph node localization and targeted dissection within 30 days.

Treatment:

Procedure: Localization

Device: Medical Device

Procedure: Axillary Lymph Node Dissection