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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-11

Study Completion Date

2021-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03718455

Breast Cancer

TERMINATED NA

Premarking of Axillary Nodes Before Start of Neoadjuvant Chemotherapy Using Magnetic Approach

NCT05625698

Breast Cancer

COMPLETED NA

Magseed Magnetic Marker Localization

NCT03020888

Disorders of Breast Breast Lesions

COMPLETED NA

Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.

NCT06463600

Breast Conserving Surgery

RECRUITING NA

Ideal Marker for Targeted Axillary Dissection

NCT04580251

Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diagnostic (Magseed marker)

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.

Group Type EXPERIMENTAL

Axillary Lymph Node Dissection

Intervention Type PROCEDURE

Undergo targeted axillary lymph node dissection

Localization

Intervention Type PROCEDURE

Undergo axillary lymph node localization

Medical Device

Intervention Type DEVICE

Receive Magseed via ultrasound guided injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Axillary Lymph Node Dissection

Undergo targeted axillary lymph node dissection

Intervention Type PROCEDURE

Localization

Undergo axillary lymph node localization

Intervention Type PROCEDURE

Medical Device

Receive Magseed via ultrasound guided injection

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ALND Axillary Dissection Axillary Lymphadenectomy Axillary Node Dissection Excision Axillary Lymph Nodes Device Medical Devices

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No