SicPin Trial: Single arm feasibility study of Pintuition for wire free localisation of non-palpable breast lesions in an Australian context

The SIC PIN trial is a focused, single-center, prospective interventional study designed to evaluate the use of the Sirius Pintuition marker clip in breast cancer diagnosis and surgery. This trial will assess the marker clip’s feasibility in assisting accurate tumor localization. The clips will be inserted by subspecialist breast Radiologists adjacent to non palpable breast tumours at Chris O'Brien Lifehouse Hospital. These patients will follow on to have surgical excision of the lesions. The procedure is done under local anaesthetic only and placed with ultrasound guidance. This is usually performed a few days prior to the planned surgical excision. The radiologists have undergone a training session with a sample Pintuition marker clip delivered by Sirius intuition through Surgeons choice. These Radiologist already have vast experience with breast marker placement. This was conducted 4 weeks prior to trial commencement. The intervention is completed once and takes 15-30 minutes approximately and this is documented in the Radiology procedure/imaging report.