Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Skin Neoplasms

Skin Diseases

Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors who are scheduled for skin biopsy or excision

Cellular resolution full-field optical coherence tomography

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

Confocal microscopy

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

Optical coherence tomography imaging

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

Dermoscopy imaging

Emily Tsai, PhD

Hsin Cheng

Martina Ulrich, MD

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.

The new high resolution OCT scanner (ApolloVue® S100 Image System, Apollo Medical Optics, Ltd. (AMO), Taiwan) is a CE-certified device, which allows non invasive imaging of the skin at high resolution. ApolloVue® S100 System provides two-dimensional, cross-sectional and en-face images which allow the real-time visualization of the skin and the assessment by physicians. OCT is an interferometry technique, which can differentiate the back- scattered light from different layers within the sample and reconstruct the microstructure of tissue. ApolloVue S100 System uses a single-crystal fiber light source (750 nm wavelength), thus allowing cellular images with an axial resolution around one micron can be achieved. The full-field OCT (FF-OCT) system utilize a camera for parallel detection to increases the scanning speed. Furthermore, by scanning an en-face image with the coherence and confocal gates matched, it does not suffer from depth-of-field limitations present in standard OCT and can achieve micron scale transverse image resolutions. AMO FF-OCT provides both high-resolution en face and B-scan imaging with decent scanning speed. Compare to traditional full-field OCT or confocal microscopy, the cross- sectional image can be shown in real-time without reconstruction after whole volume is scanned. With a simple optical switch, user can switch between two modes to improve the efficiency of lesion examination and gather more structure information. ApolloVue® S100 System is a contact imaging system with a guiding system which provides wide-range real- time color imaging to guide OCT measurement on precise position. While a measurement starts, the cart can be moved to the patient and adjust the height by lifter which covers sitting and lying positions. Then, user can precisely align the probe to a lesion by moving the arm with the guiding video which is shown on monitor. Once the lesion is aligned, user can switch the system from guiding mode to OCT modes and perform OCT scans and save the images. After the scans, user can switch back guiding mode for next position. The modes can be selected through the buttons on the probe or the computer. OCT images and the scanning positions on the guiding image will be recorded simultaneously for following up the lesion.The ApolloVue S100 System will enable the user to:

1. Acquire cross-sectional or en-face 2-dimensional OCT images of sub-surface tissue.
2. Acquire 2-dimentional OCT images of sub-surface tissue.
3. Real-time image guiding system for OCT measurement and recording position.
4. Read and manage OCT image data and annotations
5. Export OCT images as PNG and as DICOM compliant image files

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

Applicability of a Cellular Level Resolution Full-field OCT Image System (AMO, Taiwan) for the Diagnosis of Pigmented and Non-pigmented Skin Tumors

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

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

Apollo Medical Optics, Ltd

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Anti-Infective Agents

Central Nervous System Depressants

Chrysarobin

Ethanol

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.

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.

Dermoscopic imaging

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.

3-dimensional total body photography

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.).

OCT subsurface imaging shows structural-level morphology (epidermal and dermal layers) in skin down to the deeper reticular dermis.

Optical Coherence Tomography imaging

US imaging allows assessment of depth, Doppler vascular imaging, and elastography features of skin lesions.

Ultrasound

Hyperspectral imaging shows biochemical information regarding the distribution of skin melanin and hemoglobin50. SkinSpect™ is a form of a hyperspectral dermatoscope.

Hyperspectral imaging

Electrical impedance spectroscopy (EIS) measures skin's resistance to the flow of alternating electric currents to differentiate benign and malignant lesions.

Electrical impedance spectroscopy

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.

Patient self-imaging

Manu Jain, MD

Veronica Rotemberg, MD

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.

A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

Noninvasive Assessment of Muco-cutaneous Lesions In Vivo

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors	NCT05068310	Skin Lesion Skin Cancer	Cellular resolu... Confocal micros... Optical coheren... Dermoscopy imag...	18 Years -	Apollo Medical Optics, Ltd
A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions	NCT04743362	Skin Lesion Mucosal Lesion	Dermoscopic ima... 3-dimensional t... Confocal micros... Optical Coheren... Ultrasound Hyperspectral i... Electrical impe... Patient self-im...	-	Memorial Sloan Kettering Cancer Center

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