Actively Recruiting
Evaluation of Novel Iron-based Lymphatic Mapping Agent, Magtrace, for Delayed Sentinel Lymph Node Biopsy (SLNB) in Ductal Carcinoma In-Situ (DCIS)
Led by University of Florida · Updated on 2026-04-30
30
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The standard surgical approach for all patients undergoing mastectomy for the treatment of non-invasive, ductal carcinoma in situ (DCIS) is to perform axillary lymph node staging through use of a traditional sentinel lymph node biopsy (SLNB) procedure where the lymph nodes that drain the breast first are removed at the time of mastectomy. This recommendation for traditional SLNB is due to the risk of finding invasive cancer during surgical evaluation of the mastectomy specimen and the inability to accurately map the lymphatic channels once the breast is removed. In a study by Herremans et al, the majority of traditional SLNBs were demonstrated to be unnecessary. By using Magtrace, a novel iron based lymphatic mapping agent, a delayed SLNB could eliminate these unnecessary traditional SLNBs. Magtrace, or superparamagnetic oxide (SPIO), was developed in 2018. Unlike traditional mapping agents of blue dye and technetium that clear the body within 24-48 hours, Magtrace remains in the lymph nodes for at least 4 weeks. Magtrace's ability to remain in the lymph node allows accurate mapping of the lymph nodes at the time of the mastectomy with the ability to return to the operating room for a delayed sentinel lymph node biopsy if invasive cancer is found on final pathology. This study will investigate whether the use of Magtrace will successfully allow patients with DCIS undergoing mastectomy to avoid undergoing SLNB.
CONDITIONS
Official 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 63 18 years of age
- Patients with a core needle biopsy diagnosis consistent with ductal carcinoma in-situ (DCIS), Stage 0 breast cancer, planning to undergo a mastectomy
- Mastectomy may include reconstruction and/or contralateral prophylactic mastectomy
- Negative pre-operative axillary ultrasound
- Negative pregnancy test for subjects of childbearing potential before surgery
- Written informed consent and agreement to comply with study procedures
You will not qualify if you...
- Patients with contralateral invasive breast cancer requiring traditional SLNB or additional chemotherapy that may have been omitted for DCIS
- Any history of chemotherapy
- Prior ipsilateral breast cancer treated with radiation, lumpectomy, chemotherapy, or SLNB
- Ipsilateral prior axillary sentinel lymph node biopsy for other malignancy
- History of upper extremity blood clot, lymphangitis/cellulitis, lymphedema, or use of a pacemaker
- Allergy to iron, dextran, or ingredients in Magtrace
- Abnormal pre-operative axillary ultrasound
- Confirmed pregnancy
- Any disease or condition that contraindicates protocol therapy or risks treatment complications per physician
- Prisoners or involuntarily incarcerated or compulsorily detained for psychiatric or physical illness
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
S
Stephanie Portillo
CONTACT
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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