Magseed Enabled Long-Term Localization of Axillary Lymph Nodes (MAGELLAN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Axillary Lymph Nodes
• Intervention / Treatment: Device: Magseed Marker

Detailed Description

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
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matt Womack, PhD; Phone Number: +447851247439; Email: mwomack@endomag.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Sub-Investigator: Kelly Hunt, MD, F.A.C.S.
      • Contact: Veronika Noregil; Email: VYNovegil@mdanderson.org
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor Medicine
      • Contact: Ivan Marin; Email: ivan.marin@bcm.edu

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Magseed marker; Magseed marker deployed percutaneously, prior to patient undergoing neo-adjuvant chemotherapy (NAC), under ultrasound guidance to mark a lymph node intended for selective surgical removal post NAC.	Device: Magseed Marker; Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of device and serious device-related events	Rates of device-related adverse events and serious device-related adverse events	Up to 42 days post-surgery
Radiologic rated ease of Magseed placement	5 point Likert scale, very easy = 5, very difficult = 1	Time of Magseed marker placement
Radiologic placement accuracy	Success rate of seed placement (placement accuracy)	Between completion of NAC time of surgery
Radiologic seed position	Success rate of maintained seed position at the completion of NAC	After completion of NAC
Surgical nodes localized	Number of nodes retrieved within the surgical specimen containing the Magseed	Time of surgery
Ease of surgical localization	5 point Likert scalevery easy = 5, very difficult = 1	Time of surgery

Collaborators and Investigators

• Sponsor: Endomagnetics Inc
• Collaborators: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Abigail Caudle, MD, MS, MD Anderson Cancer Center, Houston, TX

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Neo-adjuvant chemotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: US-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes