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

A Prospective, Open Label Study of the Use of Magseed® and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-Proven Metastases in Breast Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Breast Carcinoma Metastatic in Lymph Node; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7
• Intervention / Treatment: Procedure: Axillary Lymph Node Dissection; Procedure: Localization; Device: Medical Device

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Axillary Lymph Node Dissection; Undergo targeted axillary lymph node dissection; Other Names: ALND; Axillary Dissection; Axillary Lymphadenectomy; Axillary Node Dissection; Excision Axillary Lymph Nodes; Procedure: Localization; Undergo axillary lymph node localization; Device: Medical Device; Receive Magseed via ultrasound guided injection; Other Names: Device; Medical Devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retrieval rate	Will be 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. For the analysis of retrieval rate, if the trial is not stopped early and all 50 patients are accrued, then point estimate along with 95% credible interval will be provided. Logistic regression model will be utilized to assess the association of patient demographic and clinical factors with the retrieval.	Up to 15 months
Incidence of adverse events	Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicity data will be summarized by frequency tables. For the toxicity endpoint, per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.	Up to 6 weeks post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiologist rated ease of Magseed placement	Descriptive statistics will be used to summarize the radiologist rated ease of Magseed placement. Logistic regression models and/or linear regression models will be used to assess the association of variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.	Up to 15 months
Accuracy of Magseed placement	Will be defined as accurate, marginal or inadequate. Descriptive statistics will be used to summarize accuracy of placement. Logistic regression models and/or linear regression models will be used to assess the association of variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.	Up to 15 months
Surgeon rated ease of node localization and removal	Descriptive statistics will be used to summarize surgeon rated ease of localization. Logistic regression models and/or linear regression models will be used to assess the association of the above mentioned variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.	Up to 15 months
Number of nodes retrieved within the surgical specimen containing the Magseed	Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed. Logistic regression models and/or linear regression models will be used to assess the association of the above mentioned variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.	Up to 15 months
Transcutaneous detection rate	Descriptive statistics will be used to summarize transcutaneous detection rate. Logistic regression models and/or linear regression models will be used to assess the association of the above mentioned variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.	Up to 15 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Abigail S Caudle, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2016-0806 (Other Identifier: M D Anderson Cancer Center); NCI-2017-00649 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No