PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients (MAGProm)

A Prospective Open Label Study of Patient Reported Outcome Measures and Efficacy Following the Use of 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients Undergoing Lumpectomy

The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

Detailed Description

The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node (SLN) detection rate in patients who have received 1ml Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures utilising BREAST-Q.

Baseline assessment using BREAST-Q will performed. A key secondary objective is to demonstrate non-inferiority of sentinel lymph node (SLN) detection rate with Magtrace compared to the American Society of Breast Surgeons (ASBRS) performance standards.

All participants will undergo lymph node mapping with Magtrace, and Sentinel Lymph Node Biopsy undertaken and nodes localised with the Sentimag system, A sentimag count will be recorded for each node removed.

After completion of the surgery, at the postoperative visit the presence of Magtrace related discoloration will be assessed by the Investigator. Participants found to have no Magtrace related discoloration will be asked to complete the Post-Op BREAST-Q assessment and return at 12 months post-op for a follow-up visit. Those patients assessed as having the presence of Magtrace related skin discoloration will be asked complete the post-op BREAST-Q and will then undergo assessment of the size and severity of the discoloration. They will then be asked to return at 6, 12, 18 and 24 months for follow-up visits, or until the discoloration has resolved. At each of these visits the BREAST-Q will be completed, and the size and severity assessment will be performed.

• Study Type: Observational
• Enrollment (Estimated): 184

Contacts and Locations

• Study Contact: Name: Vicky Crawford; Phone Number: +441223652617; Email: vcrawford@endomag.com

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • UNC, Lineberger Comprehensive Cancer Center
      • Contact: Kristalyn Gallagher
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • VCU Massey Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects considered for enrollment will be at least 18 years old at the time of consent, and: a) due to undergo planned breast conserving surgery (for example lumpectomy or partial mastectomy) and SLNB with Magtrace b) meet all other inclusion and no exclusion criteria

Description

Inclusion Criteria:

• Patient is willing and able to give informed consent for participation in the study
• Patient is aged 18 years or older at the time of consent
• Patients undergoing planned breast conserving surgery (for example, lumpectomy or partial mastectomy) and SLNB with Magtrace

Exclusion Criteria:

• The patient is pregnant or lactating
• The patient has had prior breast radiation to the ipsilateral breast
• The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
• The patient has recevied a Feraheme (ferumoxytol) injection within the past 6 months
• The patient has intolerance or hypersensitivity to iron or dextran compounds or to Magtrace
• The patient has iron overload disease
• The patient has discoloration on the breast (such as tattoo, birthmark, tanning, rash etc.), that in the Investigator's opinion, could impact the clinical trial results, specifically the assessment of any skin discoloration, or plans to have a tattoo on the breast post-operatively.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample	Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample	post-op to 24 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BREAST-Q score from post-operative visit through to resolution of skin discoloration or through 24 months, whichever is earlier, in the subgroup of patients with discoloration. 7 core scales will be used.		Baseline to 24 month follow-up
Change in BREAST-Q score from pre-operative visit to post-operative visit in patients with and without skin discoloration at the post-op follow-up visit.		Pre-op to Post-Op
Duration of discoloration over time post-op to resolution of discoloration or 24 month follow-up		Post-op to 24 month follow-up
Intensity of discoloration (absolute color and contrast to normal breast color) over time post-op to resolution of discoloration or 24 month follow-up		Post-Op to 24 month follow-up
Severity of discoloration over time post-op to resolution of discoloration or 24 month follow-up as assessed by height and width measurement		Post-Op to 24 month follow-up
Rates of device-related adverse events and serious device-related adverse events		Baseline to 24 month follow-up
Number of identified SLNs per patient	Number of identified SLNs per patient	Surgery
Number of non-Magtrace marked nodes per patient removed (clinically suspicious)	Number of non-Magtrace marked nodes per patient removed (clinically suspicious).	Surgery
Nodal malignancy rate	Nodal malignancy rate	Surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall SLN detection rate (proportion of patients with successful SLN detection using Magtrace)	Overall Sentinel Lymph Node detection rate - proportion of patients with successful SLN detection using Magtrace	Surgery

Collaborators and Investigators

• Sponsor: Endomagnetics Ltd.
• Collaborators: Endomagnetics Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Magtrace; Sentinel Lymph Node Biopsy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: US-004

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: No
• product manufactured in and exported from the U.S.: No