1 ml Magtrace for sentinel lymph node biopsy in people with breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective US study enrolls adults undergoing breast-conserving surgery with planned sentinel lymph node biopsy using 1 ml Magtrace and maps nodes with the Sentimag system. Baseline and postoperative patient-reported outcomes will be collected using the BREAST-Q, and a Sentimag count will be recorded for each removed node. Investigators will document the presence, size, and severity of any Magtrace-related skin discoloration and follow affected participants periodically up to 24 months or until discoloration resolves. A key secondary objective is to show non-inferiority of sentinel lymph node detection rates with Magtrace compared to ASBRS performance standards.

Why it matters

Who can join: the full rules

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.

Where it's running

• UNC, Lineberger Comprehensive Cancer Center
  Chapel Hill, North Carolina, United States Recruiting
• VCU Massey Comprehensive Cancer Center
  Richmond, Virginia, United States Recruiting

Study contacts

• Study coordinator: Vicky Crawford
• Email: vcrawford@endomag.com
• Phone: +441223652617

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.