Magtrace for delayed sentinel lymph node biopsy in ductal carcinoma in situ
Evaluation of Novel Iron-based Lymphatic Mapping Agent, Magtrace, for Delayed Sentinel Lymph Node Biopsy (SLNB) in Ductal Carcinoma In-Situ (DCIS)
This tests whether injecting Magtrace before mastectomy lets doctors delay sentinel lymph node biopsy and only remove nodes later for adults with DCIS.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06868238 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional study uses Magtrace, a superparamagnetic iron oxide (SPIO), injected before mastectomy because it persists in lymph nodes longer than standard tracers. If invasive cancer is found in the mastectomy specimen, a delayed sentinel lymph node biopsy can be performed using the retained Magtrace to identify nodes. The trial enrolls adults with biopsy-proven DCIS who are planning mastectomy and have a negative preoperative axillary ultrasound. Key outcomes include sentinel node identification after delay and safety measures aimed at reducing unnecessary immediate SLNBs.
Who should consider this trial
Good fit: Adults (≥18) with core-biopsy–proven DCIS planning mastectomy, a negative preoperative axillary ultrasound, and no prior ipsilateral breast cancer treatment or chemotherapy are ideal candidates.
Not a fit: Patients who require immediate SLNB—for example those with contralateral invasive cancer, positive axillary imaging, prior chemotherapy, or prior ipsilateral breast treatment—are unlikely to benefit from the delayed approach.
Why it matters
Potential benefit: If successful, this approach could spare many patients an immediate sentinel lymph node biopsy and reduce surgical complications like lymphedema.
How similar studies have performed: SPIO/Magtrace has been used in other sentinel node studies with detection rates similar to standard tracers, but the specific delayed-SLNB strategy for DCIS is newer and less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults ≥ 18 years of age. * Patients with a core needle biopsy diagnosis consistent with ductal carcinoma in-situ (DCIS), Stage 0 breast cancer, who are planning to undergo a mastectomy. o The mastectomy can be with or without reconstruction and with or without contralateral prophylactic mastectomy. * Patients with a negative pre-operative axillary ultrasound. * For subjects of childbearing potential, a pregnancy test that has resulted as negative is required preoperatively. * Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures. Exclusion Criteria: * Patients with contralateral invasive breast cancer requiring traditional sentinel lymph node biopsy at time of index operation or additional chemotherapy that may have been omitted for DCIS. * Any history of receiving chemotherapy * Prior ipsilateral breast cancer with treatment that included radiation, lumpectomy, chemotherapy, or sentinel lymph node biopsy. * Ipsilateral prior axillary sentinel lymph node biopsy for other malignancy (i.e., melanoma). * Patients with a history of upper extremity blood clot, lymphangitis/cellulitis, lymphedema, or those who use a pacemaker device * Patients with an allergy to iron, dextran, or any other ingredient in Magtrace. * Patients with an abnormal pre-operative axillary ultrasound. * Subjects who are confirmed to be pregnant. * History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. * Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Spiguel, MD — University of Florida
- Study coordinator: Stephanie Portillo
- Email: portillos@ufl.edu
- Phone: 352-273-3650
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.