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

Recruiting now

Conditions studied: Skin Lesion, Skin Cancer

In brief

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.

Key facts

Study ID

NCT05068310

Run by

Apollo Medical Optics, Ltd

People needed

200

Starts

2021-10-21

Expected to finish

2025-02-01

Last updated by the study team

2024-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• CMB COLLEGIUM MEDICUM BERLIN GmbH — Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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