NCT04743362

A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

Noninvasive Assessment of Muco-cutaneous Lesions In Vivo

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,010 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Skin Lesion
• Mucosal Lesion

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Dermoscopic imaging	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.
DIAGNOSTIC_TEST	3-dimensional total body photography	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.
DIAGNOSTIC_TEST	Confocal microscopy	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.).
DIAGNOSTIC_TEST	Optical Coherence Tomography imaging	OCT subsurface imaging shows structural-level morphology (epidermal and dermal layers) in skin down to the deeper reticular dermis.
DIAGNOSTIC_TEST	Ultrasound	US imaging allows assessment of depth, Doppler vascular imaging, and elastography features of skin lesions.
DIAGNOSTIC_TEST	Hyperspectral imaging	Hyperspectral imaging shows biochemical information regarding the distribution of skin melanin and hemoglobin50. SkinSpect™ is a form of a hyperspectral dermatoscope.
DIAGNOSTIC_TEST	Electrical impedance spectroscopy	Electrical impedance spectroscopy (EIS) measures skin's resistance to the flow of alternating electric currents to differentiate benign and malignant lesions.
DIAGNOSTIC_TEST	Patient self-imaging	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.

Timeline

• Start date: 2021-02-02
• Primary completion: 2031-08-02
• Completion: 2031-08-02
• First posted: 2021-02-08
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States