Pilot Study of Using Sirius Pintuition Magnetic Seed to Locate Non-Palpable Breast Cancer and Pathological Lymph Nodes in Surgery

What this Trial Is About

This research aims to evaluate the use of the Sirius Pintuition magnetic seed device for locating non-palpable malignant breast tumors and pathological lymph nodes in patients undergoing breast cancer surgery. The study is conducted as a prospective pilot study in the Czech Republic, focusing on improving the precision of tumor localization during surgery. This observational study involves patients with breast cancer confirmed by biopsy who require surgical treatment. Participants will have their non-palpable breast cancer or pathological lymph nodes localized using the magnetic seed Sirius Pintuition device. This device is placed to assist surgeons in accurately identifying the tumor or affected lymph nodes during surgery. The study does not involve any comparison groups or placebo treatments, as it is observational and device-focused. Throughout the study, participants will be monitored and evaluated for up to one year to assess hypotheses related to the effectiveness of the device in localization. The primary and secondary outcome measures will be reviewed after one year. Patient involvement includes undergoing the localization procedure with the device and subsequent breast cancer surgery, with follow-up to gather data on the localization process and surgical outcomes.

Localization of Breast Cancer with the Sirius Pintuition Magnetic Seed