Development of a molecular imaging fibrescope for image-guided breast cancer surgery

Surgery remains the primary treatment option for early-stage breast cancer, yet 1 in 4 patients will require re-operation after surgery. The consequences include delayed adjuvant treatment, increased likelihood of distant recurrence, poorer cosmetic outcomes, increased risk of infection, emotional distress, and enormous financial cost to the NHS. Each re-operation costs c£25k, leading to a staggering cost of £200mn and $1.5bn annually to the UK and US healthcare systems respectively. Breast cancer recurs so frequently after surgery because surgeons have no robust means to detect cancer during surgery other than visual and tactile assessment. Consequently, there is a tremendous medical need for improved tools to detect cancerous tissue during surgery.

Lightpoint Medical is developing a molecular imaging fibrescope to detect cancer in real time during surgery, and thereby reduce the need for re-operation. The technology is based on Cerenkov Luminescence Imaging (CLI), a ground-breaking imaging modality that can perform optical imaging of Positron Emission Tomography (PET) imaging agents. Initial market research indicates a high demand for Lightpoint's technology among oncology surgeons. In our TSB proof-of-concept project, we successfully completed a bench-top demonstrator of the CLI fibrescope. In this project, we will collect surgeon-user feedback on the demonstrator, and develop a full prototype for further regulatory development and pivotal clinical trials. Additionally, we will development our reimbursement roadmap and economic model.