SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer

Summary

The overall goal of this research is to develop a platform that can increase patient access to expert skin cancer diagnostic services via telemedicine. This is especially important for medically underserved areas where melanoma outcomes are worse than in areas with greater access to in-person evaluations. If successful, the widespread availability of such services would be combined with public education efforts to encourage individuals with changing skin lesions to seek evaluation. With decreased travel times to high quality diagnostic services, such efforts may decrease the diagnosis of more advanced melanomas (with a concomitant increase in the diagnosis of earlier stage tumors), and potentially decrease melanoma mortality.

Conditions

• Skin Cancer

Interventions

DEVICE

Nevisense 3.0

Nevisense, an AI-based point-of-care system for the non-invasive evaluation of irregular moles remains the only FDA approved system available for melanoma detection in the US. Nevisense 3.0 will be used as a one-time exposure of \<8 seconds per lesion. Disposable electrodes that contact the participant are 5mm x 5mm in size. Nevisense 3.0 measures electrical impedance of skin lesions and provides an output called the electrical impedence spectroscopy (EIS) score. Electrical impedance is a measure of a material's overall resistance to the flow of alternating electric currents of various frequencies. The principle is that electrical impedance is different in normal versus abnormal tissue.

DEVICE

Dermlite Cam

Dermlite Cam is a digital camera that captures images of the skin under cross-polarized and non-polarized light and is 510(k) exempt. The DermLite Cam device appears as a single piece camera with a charging cable and USB computer cable. As part of the camera unit, an extensor arm exists to allow for the capture of standardized clinical images. The DermLite Cam will be used to acquire 3 images of \<5 seconds per lesion (one clinical, one polarized dermoscopic, and one non-polarized dermoscopic). NOTE - for the purposes of this study, teledermatology images (dermoscopic and clinical - at approximately 6 inches, 12 inches, and 18 inches) were taken using the Barco Demetra after technical issues arose that prohibited the continued use of the Dermlite Cam.

PROCEDURE

Skin biopsy

A skin biopsy is a small procedure that removes a sample of skin from the surface of the body. The method utilized will be either a shave or punch technique. The maximum size of a punch biopsy will be 6mm and these wounds are generally closed with no more than 2-3 sutures. A skin biopsy takes \<15 minutes including preparation time, administration of intradermal anesthesia using lidocaine 1% with epinephrine 1:100,000, removal of the skin sample, achievement of hemostasis, dressing the wound, and providing instructions for home care. Samples will be placed formalin for routine processing.

DEVICE

Barco Demetra

Barco Demetra is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin which can then be stored, retrieved, displayed, and reviewed by medical practitioners. The Barco Demetra received 510(k) Premarket approval (K192829). The system involves a hardware imaging device and a stand-alone software application. The hardware device is a portable, battery-powered medical device for acquiring and visualizing images of the skin and uploads all images to cloud storage. The software application is cloud software with an associated web application; it can be used to visualize images and related data and can generate consultation reports. For the purposes of this study, teledermatology images (dermoscopic and clinical - at approximately 6 inches, 12 inches, and 18 inches) were taken using the Barco Demetra after technical issues arose that prohibited the continued use of the Dermlite Cam.

Sponsors & Collaborators

• NYU Langone Health

  lead OTHER

Principal Investigators

• David Polsky, MD, PhD · NYU Langone Health

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-08-20

Primary Completion

2023-03-03

Completion

2023-03-04

FDA Device

Yes

Countries

• United States

Study Locations