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

NCT04411810 | Completed Results DMC FDA Device

• 1 other identifier: 19-01242
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Accuracy of Skin Cancer Diagnosis: In-Person Assessment

  To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated.

  End of the study (4 weeks)

• Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense

  To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated.

  End of the study (4 weeks)

• Accuracy of Skin Cancer Diagnosis: Telemedicine With Nevisense

  To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated.

  End of the study (4 weeks)

Secondary Outcomes (18)

• Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense

  End of the study (4 weeks)

• Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense

  End of the study (4 weeks)

• Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer

  End of the study (4 weeks)

• Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense

  End of the study (4 weeks)

• Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense

  End of the study (4 weeks)

Study Arms (1)

Participants with skin lesions

EXPERIMENTAL

Participants who have up to 3 concerning skin lesions will be evaluated by both an in-person dermatologist and a team of three teledermatologists(board-certified dermatologists). The teledermatoogy team will deliver a consensus recommendation. If either the in-person dermatologist or teledermatologists are concerned that the skin spot(s) may be a skin cancer, a biopsy will be recommended and can be performed at no charge. Or if both agree that the spot(s) are not concerning for skin cancer, no biopsy will be needed.

Device: Nevisense 3.0; Device: Dermlite Cam; Procedure: Skin biopsy; Device: Barco Demetra

Interventions

Nevisense 3.0 DEVICE

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.

Participants with skin lesions

Dermlite Cam DEVICE

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.

Participants with skin lesions

Skin biopsy PROCEDURE

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.

Participants with skin lesions

Barco Demetra DEVICE

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.

Participants with skin lesions

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years of age or older
• Have 1-3 lesions for evaluation

You may not qualify if:

• Lesions of the hair-bearing scalp, in the mouth, on the lips, genitalia, nails, on/around the eyes, inside the ear

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: David Polsky, MD, PhD
• Organization: NYU Langone Health

David.Polsky@nyulangone.org

212-263-9087

Study Officials

• David Polsky, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 2, 2020
• Study Start: August 20, 2020
• Primary Completion: March 3, 2023
• Study Completion: March 4, 2023
• Last Updated: April 8, 2024
• Results First Posted: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to David.Polsky@nyulangone.org To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)