Skin marker device utility test
Research type
Research Study
Full title
A test of the utility of a skin marker device to enable image-guided marking of pre-surgical margins
IRAS ID
177400
Contact name
Andrew Coleman
Contact email
Sponsor organisation
R&D Department, Guy's & St Thomas' NHS Trust
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
This study will assess the feasibility and utility of image-guidance for the placement of ink marks on skin to delineate the pre-surgical margins of Basal Cell Carcinoma (BCC). The study is not designed to evaluate the clinical effectiveness of image-guided marking of BCC margins, just the feasibility and potential utility. The study represents a Work Package within the NIHR i4i project and is at a pre-clinical and pre-commercial feasibility stage. \n\nNon-invasive imaging technologies, including Optical Coherence Tomography (OCT) offer the potential for more accurate assessment of the pre-surgical border of a skin cancer by revealing sub-clinical spread. Image-guided delineation of pre-surgical margins of BCCs using OCT has been shown, for example, to reduce the recurrence rate and the need for re-excisions. However, a significant limitation of image-guided mapping of pre-surgical margins is the need for the repeated removal and replacement of the imaging probe to allow for manual marking with a standard surgical marker pen which adds time and reduces accuracy. A surgical marker pen nib has been incorporated in the imaging probe so that there is no need to remove the probe. The nib can be activated manually by the surgeon.
REC name
North of Scotland Research Ethics Committee 2
REC reference
16/NS/0135
Date of REC Opinion
5 Dec 2016
REC opinion
Favourable Opinion