Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors

Summary

The incidence of skin cancer has been continuously increasing over the past decades und the number of non melanoma skin cancer is well as melanoma is still going to increase. Invasive biopsy and histological examination represents the gold standard in diagnosis of benign and malignant skin tumors. However, novel technologies such as reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) have been introduced in dermatology. Multiple studies have shown the applicability of both technologies for diagnosis of skin tumors as well as other skin diseases and to increase the specificity of diagnosis resulting in the reduction of unnecessary biopsies. New technological developments resulted in a high resolution OCT scanner (AMO, Taiwan), which allows vertical and horizontal evaluation (3D) of the skin at cellular resolution and up to a depth of around 400 μm and thus combines the advantages of both above mentioned techniques. ApolloVue® S100 Image System is a FDA-cleared 510(k) Class II medical device. Other non-invasive imaging method (reflectance confocal microscopy and conventional optical coherence tomography) will be used to evaluate a subset of skin lesions.

Eligibility

Inclusion Criteria:

* Patients aged \> 18 years
* Willingness to participate in this study including the assessment with high resolution OCT
* Skin lesion/tumor with suspicion for skin cancer that requires skin biopsy or complete excision
* Benign skin tumor that is scheduled for excision due to suspicion, irritation or for cosmetic reason

Exclusion Criteria:

* Patients aged \< 18 years
* Any unstable medical or psychological conditions
* Unwillingness to participate in this study including the assessment with high resolution OCT

Conditions3

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