Clinical trial of an intra-operative molecular imaging camera for breast cancer surgery

Nearly 1 in 4 breast cancer patients in the UK will see their cancer return after surgery. The consequences include repeat operations, delayed adjuvant treatment, increased likelihood of distant recurrence, poorer cosmetic outcomes, emotional distress, and enormous financial cost to the NHS. Breast cancer recurs after surgery primarily due to incomplete excision of the tumour or inadequate clearance of the surgical margins. Surgeons are unable to completely remove the cancerous tissue because the only means they have to detect cancer during surgery are visual and tactile assessment. Consequently, there is a tremendous medical need for improved tools to detect cancer during surgery.
Lightpoint Medical is developing a molecular imaging camera to analyse surgical specimens in real time during surgery. 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. In this project we will undertake a pilot clinical trial of the CLI molecular imaging camera on breast cancer surgical specimens. The study will be conducted with our partners at Guy’s and St Thomas’ Hospital and King’s College, and will assess the camera's diagnostic performance compared to gold-standard pathology. The results will be used to plan the pivotal clinical trial, and design the next phase of the device.