Basal cell carcinoma margin mapping using optical coherence tomography
Research type
Research Study
Full title
A clinical evaluation of a novel system for mapping the pre-surgical margin in basal cell carcinoma using optical coherence tomography
IRAS ID
125656
Contact name
Andrew Coleman
Contact email
Sponsor organisation
Guy's And St Thomas' NHS Foundation Trust
Research summary
This is a clinical study to evaluate an in-house prototype system for guiding dermatology surgery based on a new optical imaging tool – optical coherence tomography (OCT). Currently, the pre-surgical border of a skin cancer is determined by visual inspection of the skin by a dermatologist. The possibility of invisible microscopic infiltration of the tumour beneath the skin is handled, in standard surgery, by excising a margin of 3mm or more around the border of the lesion in the expectation that this margin will include all invisible microscopic extensions.
The prototype system will allow a more accurate pre-surgical border to be delineated using the capability of OCT to image microscopic infiltration in basal cell carcinoma (BCC). This will allow the dermatologist to identify the true lateral extent of the BCC before surgery, limiting the unnecessary excision of healthy tissue.
The prototype system employs a commercial CE marked OCT system approved by the FDA for use in dermatology. The movements of the hand-held probe from this system are tracked electronically in the prototype so that the dermatologist can trace-out the border of the lesion. This border is then displayed on a PC on top of the visual image of the skin lesion allowing a direct comparison of the visual and OCT-assessed borders.
A clinical evaluation of the prototype will involve recruitment of up to 50 patients with basal cell carcinoma (BCC) who have been referred for histologically-guided surgery, known as Mohs micrographic surgery (MMS). The visually and OCT-assessed borders will be compared with the final surgical border, known as the surgical defect. The OCT-assessed border will not be used to guide surgery. Evidence that the OCT-assessed border better matches the final MMS surgical defect will be taken as proof-of-principle for this application of the prototype.
REC name
London - Dulwich Research Ethics Committee
REC reference
13/LO/0797
Date of REC Opinion
5 Jul 2013
REC opinion
Further Information Favourable Opinion