NCT06610539 PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients
| NCT ID | NCT06610539 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Endomagnetics Ltd. |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 184 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 184 participants in total. It began in 2025-04-22 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06610539 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06610539 currently recruiting?
Yes, NCT06610539 is actively recruiting participants. Contact the research team at vcrawford@endomag.com for enrollment information.
Where is the NCT06610539 trial being conducted?
This trial is being conducted at Chapel Hill, United States, Richmond, United States.
Who is sponsoring the NCT06610539 clinical trial?
NCT06610539 is sponsored by Endomagnetics Ltd.. The trial plans to enroll 184 participants.
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