FCM-P version 1

  • Research type

    Research Study

  • Full title

    Does ex-vivo fluorescence confocal microscopy allow faster evaluation of margin clearance in basal cell carcinomas in Mohs surgery: A Pilot Study (FCM-P Study)

  • IRAS ID

    212591

  • Contact name

    Eunice Tan

  • Contact email

    eunice.tan@nnuh.nhs.uk

  • Sponsor organisation

    Norfolk & Norwich University Hospital

  • Duration of Study in the UK

    0 years, 6 months, 1 days

  • Research summary

    Basal cell carcinoma (BCC) is the commonest skin cancer in the UK and its incidence is rising. At the Norfolk and Norwich University Hospital Foundation Trust (NNUHFT), we currently surgically excise approximately 3,000 basal cell carcinomas each year, 600 of which was performed with a specialised type of surgery called Mohs micrographic surgery (MMS) last year. MMS involves taking tissue for analysis with frozen sections to look for clearance of the cancer, only when the cancer is cleared is the patient reconstructed. MMS is usually reserved for BCCs on the head and neck whose margin is poorly defined, and/or at difficult anatomical sites eg around the mouth or eye, and if a complex repair such as a flap or graft will be required. MMS results in the lowest rates of BCC recurrence but is a time-consuming procedure with frozen sections taking 1-2 hours to process. In many Mohs surgery units, only small numbers of patients can be treated each day, and there is often a longer waiting list. Our laboratory is some distance away which compounds the waiting time for patients. In this study, our patient would have their normal MMS, the only difference is that the excised tissue will undergo and additional process of processing and imaging with the ex-vivo florescence confocal microscopy (FCM). Excised issue from MMS will be examined with both FCM and frozen section to determine if FCM is as accurate as frozen sections and if it really is faster than frozen sections. This could potentially speed up MMS where fewer frozen sections would be needed thereby reducing processing and microscopy time, reduce the need for repeated painful local anaesthetic injections for the patient, and reducing time and costs by reducing the number of surgical packs and time spent on prepping the sterile operating area.

  • REC name

    East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

  • REC reference

    17/EE/0037

  • Date of REC Opinion

    24 Mar 2017

  • REC opinion

    Further Information Favourable Opinion