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14000 Participants NeededMy employer runs this trial

AI Tool for Skin Cancer Diagnosis

Recruiting at 7 trial locations
AM
VR
Overseen ByVeronica Rotemberg, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to learn whether a computer-based support tool called DEXI (Dermoscopy EXplainable Intelligence) can help dermatologists decide whether a lesion may be melanoma, a serious type of skin cancer. DEXI uses artificial intelligence, or AI, which means computer technology that looks for patterns in images and information. DEXI works within a software program called the DermaGraphix Visualizer, which displays and organizes skin and lesion images. The goal of this study is to see whether DEXI can help doctors find melanoma and reduce biopsies that may not be needed.

Who Is on the Research Team?

VR

Veronica Rotemberg, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for people who have skin spots or lesions that may be cancerous or non-cancerous, such as moles, melanoma, keratoses, angiomas, and other pigmented skin changes. There are no detailed inclusion or exclusion criteria listed.

Inclusion Criteria

Presenting for an in-person office visit with an investigative provider at a participating clinical site during the study period, including referral visits and recurring skin checks
Dermatologist conducting the visit must have undergone training on how to use and interpret the CDS
I am 18 years old or older.
See 1 more

Exclusion Criteria

Telehealth-only, home, inpatient, emergency department, or procedure-only encounters without an in-office visit
Any image data captured on the patient known to have been used for training or validating DEXI

What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing an AI-based tool called DEXI to help dermatologists decide if a skin lesion might be melanoma. The tool analyzes images of the skin using computer technology to support doctors in making diagnoses and possibly reduce unnecessary biopsies.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Investigational VisitExperimental Treatment1 Intervention
Group II: Control VisitActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Canfield Scientific Inc.

Industry Sponsor

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