Status:
RECRUITING
PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients
Lead Sponsor:
Endomagnetics Ltd.
Collaborating Sponsors:
Endomagnetics Inc
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief 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 f...
Detailed Description
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node (SLN) detection rate in patients who have received 1ml ...
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.
Key Trial Info
Start Date :
April 22 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT06610539
Start Date
April 22 2025
End Date
November 1 2028
Last Update
July 4 2025
Active Locations (1)
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1
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298