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Observational Study of Magtrace® for Breast Cancer Sentinel Lymph Node Biopsy

This study is looking at how often a special liquid called Magtrace® causes skin discoloration in people with breast cancer who are having a sentinel lymph node biopsy (SLNB). SLNB is a procedure to check if cancer has spread to the lymph nodes. Researchers also want to see how well Magtrace® helps find these lymph nodes and how any skin discoloration affects patients. You might be able to join if you are 18 or older, are having breast-conserving surgery and SLNB with Magtrace®, and are not pregnant or breastfeeding. The study will track skin discoloration from right after surgery up to 24 months later.

Study design
This is an observational study planning to enroll 184 participants. It will track information about Magtrace® use in breast cancer patients.
What's involved
You will have a baseline assessment, undergo lymph node mapping with Magtrace® and SLNB, and have the presence of skin discoloration assessed after surgery. If you have no discoloration, you will complete a follow-up assessment at 12 months post-op. If you have discoloration, you will also have its size and severity assessed.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from post-surgery up to 24 months to assess skin discoloration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06610539

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

Recruiting
Not specifiedAges 18+Observational
Endomagnetics Ltd.
~184 participants
Updated 2026-03-16 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample
Measured over post-op to 24 month follow-up

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 2 states
North Carolina1
Virginia1

Who to contact

Vicky Crawford
[email protected]
+441223652617
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-samplepost-op to 24 month follow-up

    Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample