Actively Recruiting

Age: 18Years +
All Genders
NCT06610539

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

Led by Endomagnetics Ltd. · Updated on 2026-03-16

184

Participants Needed

2

Research Sites

184 weeks

Total Duration

On this page

Sponsors

E

Endomagnetics Ltd.

Lead Sponsor

E

Endomagnetics Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 received 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 could impact the assessment of skin discoloration, or plans to have a tattoo on the breast after surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

UNC, Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

2

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States, 23298

Actively Recruiting

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Research Team

V

Vicky Crawford

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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