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.
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.
Patients with a negative pre-operative axillary ultrasound.
For subjects of childbearing potential, a pregnancy test that has resulted as negative is required preoperatively.
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).
Single group
Magtrace
DrugParticipants will receive a single injection of Magtrace into the breast during their mastectomy.
Percentage of patients with DCIS who do not undergo sentinel lymph node biopsy
Determine the percentage of patients with DCIS who do not undergo sentinel lymph node biopsy.
Percentage of patients that are found to have invasive disease at time of mastectomy
Determine the Percentage of patients that are found to have invasive disease at time of mastectomy.
Rate of return to operating room for delayed sentinel lymph node biopsy
Determine the number of patients who return to the operating room for delayed sentinel lymph node biopsy.
Patient-reported outcomes measures
Compare the scores obtained to the historical control for each of the following scales of the Breast-Q questionnaire: psychosocial well-being, sexual well-being, cancer worry, fatigue, and impact on work.
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