Skin cancer is the most common type of cancer in the UK, with over 100,000 cases diagnosed each year. Melanoma skin cancer is likely to develop from a mole, however, suspicious moles are often difficult to diagnose by eye, even for experts working in specialist skin cancer screening clinics. In the UK, 350,000 patients per year are referred to hospital clinics with suspicious moles, and approximately half undergo a biopsy to identify the 5-10% who require further treatment.
Typically, a dermatologist diagnoses skin abnormalities based on clinical history and examination, aided by using a bedside magnification device (dermatoscope). If cancer cannot be ruled out, the lesion is surgically removed.
Reflectance confocal microscopy (RCM) is a non-invasive real-time imaging technique used at the bedside. VivaScope 1500 and 3000 (distributed by MAVIG, manufactured by Caliber Imaging & Diagnostics) use near infrared point-laser light to image the top layers of the skin, blood vessels, and pigment with a cellular resolution. VivaScope can assist dermoscopy in identifying whether or not a suspicious mole is cancerous. It allows clinicians to see the skin lesion in greater detail than dermoscopy and adds certainty to their diagnosis, allowing specialists to see any cancer cells in a mole.
A number of studies from countries outside of the UK have shown that VivaScope improves melanoma diagnosis when used as an adjunct to dermoscopy. This study will examine patients with suspicious moles and cancerous skin lesions to determine whether confocal microscopy can both reduce the number of unnecessary biopsies and reduce the amount of tissue extracted during surgical removal in patients in the UK.
Study status: This study is currently being reviewed for funding. If funding is allocated, the study will then go through an ethics approval process prior to beginning data collection. The estimated start date after obtaining funding is July 2017.