Title: Image-guided mapping of pre-surgical margins in skin cancer
Funder: Department of Health and Social Care

Abstract: This is a three year project. It has been divided into four 8-month development and testing Work Packages with a 4-month commercialisation phase (Work Package 5). The underpinning MarginMapper technology, combining touch-screen and ink-jet, will be developed in Work Packages 1. A demonstration prototype of the MarginMapper incorporated with a commercial optical coherence tomography (OCT) system will be developed in Work Package 2. This demonstration prototype will be tested for accuracy and validated in the clinic for BCC margin-mapping in Work Package 3. This constitutes the first two years' effort. In the final year (Work Package 4) the underpinning MarginMapper technology will be incorporated with a second imaging modality (Digital Dermoscopy). This will demonstrate the technology s versatility and extend its application to other skin cancers, including SCCs and BCCs. This Work Package will include accuracy testing and validation in the clinic for a range of skin cancers. Work Package 5 involves all commercialisation issues: development of the business plan including market research and development of the business proposition, financial model and market entry strategy. PA Consulting Group (acting as sub-contractors) will develop the underpinning technology and deliver the OCT- and DD-MarginMapper prototypes. The National Physical Laboratory (NPL) (acting as a partner) will evaluate the accuracy with which ink can be deposited by the prototypes under lab conditions. The hospital (GSFT) will clinically validate the prototypes and be responsible for project management, medical device regulatory issues, scientific oversight, IP protection and exploitation. King s College London (KCL) will oversee imaging software development. GSFT will lead on the commercialisation. The following Work Pakages, with a summary of their content, will make up the 3 years of the project:- Work Package 1. Design MarginMapper Technology Platform (8 months) Activities Develop simplified print concept and identify print technology for the application Develop system architecture, hardware and software features that will form part of the prototype Deliverables Demonstrate printing under touch-screen control Underpinning technology and system documentation Milestone Underpinning print and touch-screen technologies identified, integrated and successfully demonstrated Work Package 2. Develop OCT-MarginMapper prototype (8 months) Activities Source, develop, build and test candidate print technology for commercial VivoSight OCT system Mechanical design and development of the printing hardware Test integration of print technology with prototype OCT demonstrator system Deliverables OCT-MarginMapper prototype with characterised functionality Milestone Delivery of a functioning OCT-MarginMapper demonstrator prototype Accuracy Work Package 3. Accuracy testing and clinical validation of OCT-MarginMapper (8 months) Activities Calibration of OCT-MarginMapper Measurement of the deviation of each ink mark from the nominal position on an artefact. Clinically validate the OCT-MarginMapper Deliverables Measurement procedure, calibration and measurement artefact. Report on system results of accuracy tests Milestone Accuracy Work Package 4. Develop, test and validate DD-MarginMapper prototype Activities (8 months) Activities Mechanical design and development of the printing hardware Source, develop, build and test candidate print technology Test integration of print technology with prototype DD-demonstrator system Test Accuracy and clincially validate the DD-MarginMapper Deliverables DD-MarginMapper prototype with characterised functionality Milestone Delivery of a functioning DD-MarginMapper demonstrator prototype Accuracy Work Package 5. Commercialisation (4 months) Activities Assess current market, competitive and regulatory trends in US and Europe Define the supply and value chain, and key stakeholder groups Develop value positioning across the supply Define Unique Selling Propositions for each stakeholder group Develop outline financial model (volume, cost, margin) Financial model implications on attractiveness to stakeholder groups Develop a set of market entry options Protect and manage IP Deliverables Market analysis document Financial model Strategy for market entry Milestone A viable business case Investors/industry partners identified

Lay abstract: Basal cell carcinoma (BCC) accounts for around 75 per cent of all skin cancers, and is linked to overexposure of skin to ultraviolet light. A recent study shows that basal cell carcinoma (BCC) is the commonest malignant disease in the UK, with the number of cases having risen by 80% in a decade. Most BCCs and other skin cancers are treated by surgical removal. A fundamental problem in surgical removal of BCC and other skin cancers is determining the amount of tissue to cut-out around the cancer: too little and the cancer recurs, too much and the treatment is unnecessarily aggressive, removing healthy tissue and leaving a larger wound that may look unsightly and which can cause complications. Currently, the surgeon judges the extent of the cancer by eye, including a safety margin of skin (between 3-10mm) around the visible border of the cancer to catch any invisible infiltration of the disease. Sometimes, however, the disease will have infiltrated beyond the safety margin . New non-invasive imaging technologies can now track cancers as they grow invisibly underneath skin. This can help the surgeon decide how much tissue to cut out. However, these technologies are not used routinely because it takes too long. Our team are looking to develop a device for use with new imaging technologies to guide the surgeon in mapping the extent of the spread of the cancer in a manner that is quick and easy enough for routine clinical use. The prototype Margin Mapper , will combine two established technologies (ink-jet and touch-screen) to deposit ink on the skin at the precise position corresponding to the surgical margin of the cancer in response to the surgeon tracing the margin as it appears in the image.

Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES;4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: CANCER AND NEOPLASMS