Actively Recruiting
Evaluation of Novel Iron-based Lymphatic Mapping Agent Magtrace for Delayed Sentinel Lymph Node Biopsy in Ductal Carcinoma In Situ (DCIS)
Led by University of Florida · Updated on 2026-06-08
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Magtrace, a new iron-based lymphatic mapping agent, for patients with ductal carcinoma in situ (DCIS) undergoing mastectomy. The study aims to determine if Magtrace can help avoid unnecessary traditional sentinel lymph node biopsies (SLNB) by allowing a delayed SLNB only if invasive cancer is found after surgery. This Phase 2 trial builds on findings that many traditional SLNBs may be unnecessary and explores a safer, more targeted approach. Participants will receive a single injection of Magtrace into the breast during their mastectomy surgery. Unlike traditional mapping agents that clear quickly, Magtrace remains in the lymph nodes for at least four weeks, enabling accurate delayed lymph node mapping if needed. The mastectomy may be performed with or without reconstruction and may include contralateral prophylactic mastectomy. Throughout the study, researchers will track how many patients avoid SLNB, the presence of invasive disease at mastectomy, rates of return to surgery for delayed SLNB, and patient-reported outcomes over 24 months post-mastectomy. Safety, adherence, and the accuracy of lymph node mapping will be monitored. Participants will be followed for two years to assess long-term results and any need for further procedures.
CONDITIONS
Brief Title
Evaluation of Novel Iron-based Lymphatic Mapping Agent, Magtrace, for Delayed Sentinel Lymph Node Biopsy (SLNB) in Ductal Carcinoma In-Situ (DCIS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Diagnosis of ductal carcinoma in situ (DCIS), Stage 0 breast cancer, confirmed by core needle biopsy
- Planning to undergo mastectomy, with or without reconstruction, and with or without contralateral prophylactic mastectomy
- Negative pre-operative axillary ultrasound
- Negative pregnancy test for subjects of childbearing potential
- Provided written informed consent and agree to follow study procedures
You will not qualify if you...
- Contralateral invasive breast cancer requiring traditional sentinel lymph node biopsy or additional chemotherapy
- History of receiving chemotherapy
- Prior ipsilateral breast cancer treated with radiation, lumpectomy, chemotherapy, or sentinel lymph node biopsy
- Prior ipsilateral axillary sentinel lymph node biopsy for another cancer
- History of upper extremity blood clot, lymphangitis/cellulitis, lymphedema, or use of a pacemaker device
- Allergy to iron, dextran, or any ingredient in Magtrace
- Abnormal pre-operative axillary ultrasound
- Confirmed pregnancy
- Any disease or condition that contraindicates study therapy or affects study results, as judged by physician
- Prisoners or involuntarily incarcerated individuals, or those compulsorily detained for psychiatric or physical illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At the time of mastectomy
Participants receive a single injection of Magtrace into the breast during their mastectomy.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
S
Stephanie Portillo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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