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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
Sponsor: Endomagnetics Ltd. · Participants: 184 · Started: Apr 22, 2025
Contact the study team
- Vicky Crawford · Phone: +441223652617
Official record on ClinicalTrials.gov — NCT06610539
Locations in the U.S.
| North Carolina | UNC, Lineberger Comprehensive Cancer Center, Chapel Hill |
| Virginia | VCU Massey Comprehensive Cancer Center, Richmond |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.