Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

Endomagnetics Ltd.65 enrolled

Overview

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.

This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed to mark the metastatic node and are having that clipped node selectively removed at surgery following neo-adjuvant chemotherapy (NAC). Subjects will have the Magseed placed to mark axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before initiating NAC. After completion of NAC, the Magseed will be localized using the Sentimag system during surgery and removed with the targeted lymph node.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Axillary Lymph Nodes

Interventions

Magseed MarkerDEVICE

Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Baylor Medicine

Houston, Texas, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Retrieval rate of clipped node and Magseed in the excised specimen

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.

Time frame: Time of surgery

Secondary Outcomes

Rates of device and serious device-related events

Rates of device-related adverse events and serious device-related adverse events

Time frame: Up to 42 days post-surgery

Radiologic rated ease of Magseed placement

5 point Likert scale, very easy = 5, very difficult = 1

Time frame: Time of Magseed marker placement

Radiologic placement accuracy

Success rate of seed placement (placement accuracy)

Time frame: Between completion of NAC time of surgery

Radiologic seed position

Success rate of maintained seed position at the completion of NAC

Time frame: After completion of NAC

Surgical nodes localized

Number of nodes retrieved within the surgical specimen containing the Magseed

Time frame: Time of surgery

Ease of surgical localization

5 point Likert scalevery easy = 5, very difficult = 1

Time frame: Time of surgery

Central Contacts

Matt Womack, PhD

CONTACT

+447851247439 mwomack@endomag.com

Data from ClinicalTrials.gov

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