Magseed Pro®/Sentimag® Gen3: A new system for preoperative marking of affected breast tissue and lymph nodes in patients with breast cancer

Breast cancer (mammary carcinoma) is a malignant disease of the breast tissue characterized by the uncontrolled proliferation of breast cells. Treatment for breast cancer at a locally confined stage with no evidence of distant metastases (spread of cancer cells to other organs) typically involves breast-conserving surgery preceded by chemotherapy (neoadjuvant therapy), with the goal of complete recovery. Marking the affected tissue and lymph nodes is necessary before surgery if tumors or lymph nodes are not palpable, are very small, are located deep within the tissue, or are barely visible following prior treatment such as chemotherapy. This helps surgeons precisely locate the affected tissue during surgery and remove it completely. As a result, surgery can be performed in a way that minimizes tissue damage, increases the success rate, and reduces the risk of follow-up surgeries. Marking is an important tool for safe and targeted treatment, particularly in breast-conserving surgeries or the removal of individual affected lymph nodes.

Currently, marking is performed, among other methods, by inserting a wire or a radioactive substance. In wire marking, a thin wire is inserted into the tumor on the day of surgery under imaging guidance; the end of the wire protrudes from the skin and serves as a guide for the surgeon. This method is well-established but is often uncomfortable for patients and inflexible in its application. The radioactive seed method uses a small marker with low-level radiation that is implanted into the tissue a few days in advance. It can be located during surgery using a detection device, but it requires strict safety precautions and is not available everywhere.

The new Magseed Pro®/Sentimag® Gen3 system could offer a modern alternative. The system consists of the Magseed Pro® magnetic marker and the Sentimag® Gen3 detection device. The marker is implanted into the target tissue under imaging guidance a few days before surgery and remains anchored there. During surgery, the Sentimag device detects the marker via a magnetic field and precisely indicates its location and distance to the surgeon. The Magseed Pro®/Sentimag® Gen3 system enables the marking of both breast tumors and affected lymph nodes. The system is CE-certified and has already been approved for use.

The aim of this study is to investigate whether the Magseed Pro®/Sentimag® Gen3 system is safe and effective for marking tumors in the breast area and affected lymph nodes prior to surgery. As part of the study, all patients will undergo marking using the Magseed Pro®/Sentimag® Gen3 system, and the study is open-label, meaning that both medical staff and patients are aware of which method is being used. The duration of participation varies between 1 and 38 weeks, depending on when the patient is enrolled in the study (based on the surgery date and follow-up). The study’s primary focus is on the proportion of patients in whom the marker was successfully placed in the tissue and the affected site was subsequently located and removed during surgery.

Women and men aged 18 and older with breast cancer or precancerous breast lesions may participate in this study. A prerequisite is that the tumor and/or confirmed or suspected affected lymph nodes are scheduled to be marked prior to surgery and subsequently removed.