Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy

Study Overview
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Brief Summary
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The aim of this study is to evaluate the imaging performance of Spectrally Encoded Confocal Microscopy (SECM) for imaging human skin and skin diseases.

Detailed Description
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SECM provides an order of magnitude faster imaging speed than conventional confocal microscopy devices. The investigators have previously utilized the SECM technology for imaging large area of human esophagus in vivo. They have also developed endoscopic capsule devices which have been used to safely image over 60 human subjects, healthy volunteers and subjects with eosinophilic esophagitis, using SECM technology, rapidly. When used for skin imaging, SECM can provide real-time three-dimensional confocal imaging and significantly reduce the imaging time. While SECM has been successfully used for imaging human esophagus in vivo, its utility in skin imaging needs to be tested in a new pilot study. The investigators will be taking images with a dermatoscope as well. This will the control to compare the experimental images to, as the dermatoscope is the standard of care diagnostic tool for dermatologists.

Official Title
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Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy

Conditions
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Pigmented Lesions, Pigmented Skin Lesion, Pigmented Moles, Skin Lesion

Intervention / Treatment
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* Device: SECM Skin Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults 18 years of age or older Capable of giving informed consent Pigmented lesions (such as moles) present on the forearm Exclusion Criteria: Unable to provide consent Open cuts/sores on the skin, skin infection, or any contagious skin condition Pregnant women (according to subject) Employees under the direct supervision of the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SECM Skin Imaging<br>The SECM skin imaging procedure will be very similar to that by the FDA approved RCM devices. First, the skin lesion (such as a mole) will be identified on a forearm of the subject. The lesion will be imaged first with a dermatoscope, and then with the SECM device. A dermatoscope is a hand-held device used for the visual observation of the epidermis. It is a superior surface contact microscope used to examine skin lesions. | Device: SECM Skin Imaging<br>* Consented Participants will be asked to allow their forearm to be imaged by the dermatoscope on the same skin/lesions as a control comparison. We will be trying to image pigmented skin/lesions present on the forearm. This will be followed by imaging using the SECM Skin imaging device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of SECM device to image skin and skin diseases | The quality, resolution and depth of the images will be reviewed by the PI. This is a qualitative analysis to determine the feasibility of the device, the parameters mentioned will be compared to correlative data obtained from the dermatoscope control. Unit measurements are not available. | Imaging data is collected during the procedure, and analyzed within 1 year of collection. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SECM, Spectrally Encoded Confocal Microscopy, RCM, Reflectance Confocal Microscopy