Magseed Magnetic Marker Localization

A Prospective, Open Label, Post Marketing Study of Magseed and Sentimag in Patients Undergoing Surgical Excision of a Breast Lesion That Requires Preoperative Radiographic Localization

The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.

Study Overview

• Status: Completed
• Conditions: Breast Lesions; Disorders of Breast
• Intervention / Treatment: Device: Magseed and Sentimag

Detailed Description

This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in patients undergoing surgical excision of a breast lesion.

Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior to surgery.

The Magseed marker will be localized using the Sentimag system during surgery and removed with the lesion.

After the lumpectomy procedure, subjects will be evaluated for safety and patient reported outcomes.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030-4008
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Subjects with a breast lesion requiring image-guided localization prior to excision.
• Subjects aged 18 years or more at the time of consent.

Exclusion Criteria:

• The subject is pregnant or lactating.
• Subject has pacemaker or other implantable device in the chest wall.
• Subject has current active infection at the implantation site in the breast (per investigatordiscretion)

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 and Sentimag; Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion.	Device: Magseed and Sentimag; Magseed marker and Sentimag probe for lesion localization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants With Retrieval of Index Lesion and Magseed	Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.	Time of surgery on average 16 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Device Related Adverse Events	Rates of device-related adverse events and device-related serious adverse events	8 weeks
Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy	Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy & Difficult after each marker placement.	At the time of marker deployment on average 8.39 minutes
Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion	Success rate of Magseed placement relative to the lesion (placement accuracy) measured as <5mm to lesion; 5-10mm to lesion; >10 mm to the target	At time of marker deployment on average 8.39 minutes
Percentage of Participants With Re-excision	Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion	During surgery on average 16 minutes
Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy	Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise	At time of surgery on average 16 minutes
Surgical Localization - Duration of Localization	Duration of the lumpectomy procedure, time taken to remove the lesion	At time of surgery on average 16 minutes
Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy	Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy	On the day of surgery

Collaborators and Investigators

• Sponsor: Endomagnetics Inc
• Collaborators: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Kelly Hunt, MD, MD Anderson

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: January 16, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases
• Other Study ID Numbers: US-002

Plan for Individual participant data (IPD)

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