RecruitingNCT06610539

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

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

Sponsor

Endomagnetics Ltd.

Enrollment

184 participants

Start Date

Apr 22, 2025

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria7

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.