A Multicenter Registry Study of Breast Microseed Treatment for Early Stage Breast Cancer

What this Trial Is About

This research focuses on women diagnosed with early stage breast cancer who typically receive lumpectomy followed by radiation therapy. The study evaluates a technique called Permanent Breast Seed Implant (PBSI), which delivers radiation to a portion of the breast where cancer is more likely to recur, rather than to the whole breast. PBSI aims to reduce the side effects associated with whole breast radiation, such as skin burns and prolonged treatment times, by using permanently implanted radioactive seeds. The PBSI procedure is done on an outpatient basis under local anesthesia and light sedation, after the surgery when the scar has healed and final pathology is available. It involves inserting stranded radioactive seeds into the target breast tissue guided by imaging, delivering low dose rate radiation over time. This method contrasts with traditional whole breast radiation that requires daily treatments over several weeks. The study collects data from multiple centers to ensure proper clinician training and to evaluate long-term safety and rare complications. Participants will be monitored for up to 10 years after the implant procedure with assessments including serious adverse events, breast cancer recurrence, side effects of PBSI, cosmetic outcomes, and survival status. Follow-up includes imaging, clinical evaluations, and quality assurance measures. This long-term data collection helps researchers understand the safety and effects of PBSI when performed by various practitioners across different centers.

A Registry Study of Breast Microseed Treatment