1 ml Magtrace for sentinel lymph node biopsy in people with breast cancer
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
This study will try to find how often Magtrace causes skin discoloration and whether it reliably finds sentinel lymph nodes in people having breast-conserving surgery for breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 184 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Endomagnetics Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Trial ID | NCT06610539 on ClinicalTrials.gov |
What this trial studies
This prospective US study enrolls adults undergoing breast-conserving surgery with planned sentinel lymph node biopsy using 1 ml Magtrace and maps nodes with the Sentimag system. Baseline and postoperative patient-reported outcomes will be collected using the BREAST-Q, and a Sentimag count will be recorded for each removed node. Investigators will document the presence, size, and severity of any Magtrace-related skin discoloration and follow affected participants periodically up to 24 months or until discoloration resolves. A key secondary objective is to show non-inferiority of sentinel lymph node detection rates with Magtrace compared to ASBRS performance standards.
Who should consider this trial
Good fit: Adults (18+) who can consent and are scheduled for breast-conserving surgery with sentinel lymph node biopsy using Magtrace are ideal candidates.
Not a fit: People who are pregnant or lactating, have prior ipsilateral breast radiation, clinical/radiologic metastatic nodes, recent ferumoxytol, iron overload, hypersensitivity to iron/dextran/Magtrace, or preexisting breast discoloration that would confound assessments are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could support wider use of Magtrace as a non-radioactive option that reliably identifies sentinel nodes with a low rate of lasting skin staining.
How similar studies have performed: International studies of Magtrace have shown comparable sentinel node detection rates to conventional tracers but have also reported skin staining, and prospective US-specific data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chapel Hill, North Carolina and 1 other locations
- UNC, Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
- VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Vicky Crawford
- Email: vcrawford@endomag.com
- Phone: +441223652617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.