Health TrialsbyHealthPanel

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

ConditionsSkin LesionSkin Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorApollo Medical Optics, Ltd

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients aged < 18 years

Any unstable medical or psychological conditions

Unwillingness to participate in this study including the assessment with high resolution OCT

Trial population

Patients with suspicious skin lesion/tumor that requires skin biopsy or complete excision

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Cellular resolution full-field optical coherence tomography

    Device

    Device: ApolloVue® S100 Image System

  • Confocal microscopy

    Device

    Device: Vivascope® will be used for skin imaging for a subset of skin lesions.

  • Optical coherence tomography imaging

    Device

    Device: Vivosight® will be used for skin imaging for a subset of skin lesions.

  • Dermoscopy imaging

    Device

    Device: Dermoscopy imaging will be conducted using but not limited to dermoscope DermLite FotoX®

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors4 interventions

Trial outcomes

Primary outcomes

1

Characterization of the disease features of pigmented and non-pigmented skin lesions

This is an observational study. The morphologic patterns of pigmented and non-pigmented skin lesions will be examined (% lesions that demonstrate descriptor examined).

Time frame
1.5 year

Secondary outcomes

1

Diagnostic accuracy of pigmented and non-pigmented skin lesions

The diagnostic accuracy (sensitivity and specificity) of pigmented and non-pigmented skin lesions will be determined.

Time frame
1.5 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Apollo Medical Optics, Ltd

Lead sponsor

Source ClinicalTrials.gov
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