Early Feasibility Study: Application of OCT Imaging in Dermatology

Study Overview
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Brief Summary
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Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture biological images from within optical scattering media (e.g., biological tissue). A high-resolution OCT has the characteristics of non-invasive, label-free, real-time, cellular resolution with high tissue penetration depth that are highly valuable for clinical use. AMO has developed an in-vivo OCT scanning system prototype based on the clinical needs and potential applications. This study is designed as an early feasibility study aiming for validation of AMO's in-vivo OCT scanning system in dermatology through collaboration with Mackay Memorial Hospital. The OCT can provide cellular-resolution (<1μm in lateral and axial directions) images which can be utilized to identify organelles. A high-resolution OCT has the characteristics of non-invasive, label-free, real-time, cellular resolution with high tissue penetration depth that are highly valuable for clinical use. The proposed scenario in this study is to collecting OCT images of skins with suspicious lesion including tumor, inflammatory diseases or pigment alteration as well as normal skin by using AMO's in vivo OCT imaging system. By using traditional pathological biopsy images or dermoscopic images as gold standard references, investigators will try to identify different characteristics in OCT images of skin with suspicious lesion including tumor, inflammatory diseases, or pigment alteration as well as normal skins.

Official Title
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Early Feasibility Study: Application of OCT Imaging in Dermatology

Conditions
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Skin Diseases

Intervention / Treatment
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* Device: ApolloVue™ S100 image system, Viper1-S003


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient who is fully aware of the trial and can sign the inform consent form himself/herself Patients with suspected skin tumors or skin inflammations Patients diagnosed for biopsy Patients with no open wounds in the tumor or inflamed position Exclusion Criteria: Patients with a transcutaneous infectious disease Patients under the age of 20 Vulnerable populations, including: pregnant women, handicapped, and homelessness Patient cannot cooperate in examination Patients with skin tumors that are in the subcutaneous tissue

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental<br>Suspected skin inflammations or skin tumors | Device: ApolloVue™ S100 image system, Viper1-S003<br>* The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 6 medical images of normal and lesional skin, respectively, for experimental group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with clear tissue characteristics of skin diseases and/or normal skin in tomograms | Number of subjects with clear tissue characteristics of tomograms will be compared to that with unclear tissue characteristics to identify the effect of the OCT on scanning skin at study completion. | 2 years | 
| Number of subjects with the distinction between skin lesion and normal skin in tomograms | Number of subjects with the distinction between skin lesion and normal skin in tomograms will be compared to that with no distinction to verify the specific diseases that can be distinguished from others by the OCT at study completion. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with clear tissue stratification of skin diseases and/or normal skin in tomograms | Number of subjects with clear tissue stratification, eg. dermal-epidermal junction, of tomograms will be compared to that with unclear tissue stratification to identify the effect of the OCT on scanning skin at study completion. | 2 years | 
| Number of subjects with the similarity of tissue characteristics, tissue stratification, and tissue thickness between tomograms and H&E stain | Number of subjects with the similarity of tissue characteristics, tissue stratification, and tissue thickness between tomograms and H&E stain will be compared to that with no similarity to verify whether the tomograms are comparable with gold standard methods H&E stain images at study completion. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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optical coherence tomography (OCT), dermatology, skin diseases, pathology, H&E stain