A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

Study Overview
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Brief Summary
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The purpose of this study is to find out whether using noninvasive methods to study the appearance of lesions can improve diagnostic accuracy before a biopsy is required and help guide treatment planning. The database created to store these images is called an Image Repository, and it will be used to support clinical practice, teaching and training, and future research.The High-resolution OCT (Apollo Medical Optics) device ApolloVue® S100 Image System (medical device Class II) can provide both cross-sectional and en-face images with cellular information.

Official Title
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Noninvasive Assessment of Muco-cutaneous Lesions In Vivo

Conditions
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Skin Lesion, Mucosal Lesion

Intervention / Treatment
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* Diagnostic Test: Dermoscopic imaging
* Diagnostic Test: 3-dimensional total body photography
* Diagnostic Test: Confocal microscopy
* Diagnostic Test: Optical Coherence Tomography imaging
* Diagnostic Test: Ultrasound
* Diagnostic Test: Hyperspectral imaging
* Diagnostic Test: Electrical impedance spectroscopy
* Diagnostic Test: Patient self-imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All ages Patients with a muco-cutaneous lesion(s) amenable to imaging by non-invasive tools Healthy volunteer subjects Ability to give informed consent or in the case of pediatric patients, assent and consent from the parent/guardian Exclusion Criteria: Allergy or intolerance to ultrasound gel or mineral oil used for imaging Patients who are not able to comply with imaging procedure
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with muco-cutaneous lesions<br>Participants will have muco-cutaneous lesions for non-invasive evaluation (including normal skin or mucosa and benign lesions) and will be identified by their physicians or fellows during routine clinical care. | Diagnostic Test: Dermoscopic imaging<br>* The skin lesion will be imaged before application of alcohol (spray/wipe) and after application of alcohol (spray/wipe). The dermatoscope/camera with dermoscopy imaging capabilities, including but not limited to VEOS® SLR (Canfield Scientific, Inc.), will be placed on/near the area(s) of interest. Images will be captured in polarized and/or nonpolarized modes and contact and/or non-contact modes.<br>Diagnostic Test: 3-dimensional total body photography<br>* Participants will stand in the center of an imaging station consisting of 92 high-resolution cameras. Image capture by all cameras will occur simultaneously, (approx. 3 milliseconds). Within a few minutes, specialized software will process and assemble the images into a 3D avatar - a digital model of the patient's skin - showing all his or her lesions.<br>* Other names: 3D TBP;Diagnostic Test: Confocal microscopy<br>* CM imaging (Vivascope®, Caliber Imaging and Diagnostics, Rochester, NY) will be performed using an arm-mounted CM device (Vivascope1500, Caliber I.D., Inc.) or using a handheld CM device (Vivascope3000, Caliber I.D., Inc.).<br>* Other names: CM;Diagnostic Test: Optical Coherence Tomography imaging<br>* OCT subsurface imaging shows structural-level morphology (epidermal and dermal layers) in skin down to the deeper reticular dermis.<br>* Other names: OCT imaging;Diagnostic Test: Ultrasound<br>* US imaging allows assessment of depth, Doppler vascular imaging, and elastography features of skin lesions.<br>* Other names: US;Diagnostic Test: Hyperspectral imaging<br>* Hyperspectral imaging shows biochemical information regarding the distribution of skin melanin and hemoglobin50. SkinSpect™ is a form of a hyperspectral dermatoscope.<br>Diagnostic Test: Electrical impedance spectroscopy<br>* Electrical impedance spectroscopy (EIS) measures skin's resistance to the flow of alternating electric currents to differentiate benign and malignant lesions.<br>* Other names: EIS;Diagnostic Test: Patient self-imaging<br>* Clinical and dermoscopy self-imaging by patients can be accomplished using mobile phone technology. In the case of dermoscopy, this requires a small dermatoscope attachment for the phone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions | The primary outcome of this study is to collect images from varied images devices with the dermatology service and to create an effective mechanism for the storage and dissemination of the resultant images for research purposes. | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muco-cutaneous lesion, skin lesion, mucosal lesion, Memorial Sloan Kettering Cancer Center, 21-019