Study of Delayed Sentinel Lymph Node Biopsy Using SPIO Nanoparticles in Women With Ductal Carcinoma In Situ or Suspicious Breast Lesions

What this Trial Is About

This research investigates the use of superparamagnetic iron oxide SPIO nanoparticles as a tracer for delayed sentinel lymph node dissection d-SLND in women with breast conditions where immediate axillary surgery is not needed. This includes patients with a preoperative diagnosis of ductal carcinoma in situ DCIS, unclear suspicious breast lesions, or those planned for risk-reducing mastectomy. The study aims to assess the effectiveness and accuracy of the delayed SLND approach, allowing some patients to avoid upfront surgery in the axilla. Participants receive an injection of SPIO near the breast lesion during their primary breast surgery, either up to 24 hours before or during the operation. If the final pathology shows invasive breast cancer, a second operation is performed to remove the sentinel lymph nodes SLNs using either SPIO or a radioactive tracer, depending on random assignment. The procedure involves multiple steps including detection of magnetic and radioactive signals, incision, SLN identification, and removal. Blue dye may also be used to assist in locating the nodes. During the study, patients undergo initial breast surgery with SPIO injection and magnetic signal detection but no immediate SLN removal. If invasive cancer is found, the delayed SLND procedure is done later with additional tracers. Researchers measure detection rates of SLNs, concordance between methods, and malignancy rates. Safety and procedure success are closely monitored. The study includes a control group receiving standard upfront SLND, and participants are followed until the study ends in 2027.

Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ