NCT07890415 · Memorial Sloan Kettering Cancer Center
Using an Artificial Intelligence (AI) Tool for Melanoma Diagnosis
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Clinical decision support tool
Clinical decision support tool (CDS) featuring the DEXI (Dermoscopy EXplainble Intelligence) algorithm within the setting of outpatient dermatology visits at both a dedicated cancer center dermatology service (MSK) and general medical dermatology clinics within a large health network (SU), where melanoma screening or assessment occurs as part of standard care.
Primary outcome measures
Overall melanoma detection rate per visit
Time frame: up to 4 years
The primary objective is to evaluate the impact of a clinical decision support tool (CDS) on precision to diagnose melanoma within in-office dermatology visits. Melanoma detection efficiency will be measured (a) total biopsies to rule out melanoma per 100 visits and (b) melanoma diagnosed per 100 visits, compared between visits carried out under standard of care (SOC) versus visits in which the dermatologist (provider) has access to the CDS (enhanced visits).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 years or older at the time of scheduling the office visit.
- Presenting for an in-person office visit with an investigative provider at a participating clinical site during the study period. Both referral visits and recurring skin checks are eligible.
- Visit must have a mapped ICD-10 code with at least one of the following: ii. iii. C43 - Malignant melanoma of skin C44 - Other and unspecified malignant neoplasm of skin D03 - Melanoma in situ iv. D04 - Carcinoma in situ of skin v. D18.0 - Hemangioma vi. D22 - Melanocytic nevi vii. D23 - Other benign neoplasms of skin viii. D48.5 - Neoplasm of uncertain behavior of skin ix. D48.9 - - Neoplasm of uncertain behavior, unspecified x. D49.2 - Neoplasm of unspecified behavior of bone, soft tissue, and skin xi. I78.1 - Nevus, non-neoplastic xii. L57 - Skin changes due to chronic exposure to nonionizing radiation xiii. L73.8 - Other specified follicular disorders xiv. L81.4 - Other melanin hyperpigmentation xv. L82 - Seborrheic keratosis xvi. Q82.5 - Congenital non-neoplastic nevus xvii. Z12.83 - Encounter for screening for malignant neoplasm of skin xviii. Z80.8 - Family history of malignant neoplasm of other organs or systems xix. Z85.82 - Personal history of malignant neoplasm of skin xx. Z86.006 - Personal history of melanoma in-situ xxi. Z86.007 - Personal history of in-situ neoplasm of skin
- Dermatologist conducting the visit must have undergone training for the how to use and interpret the CDS.
Exclusion criteria
- Telehealth-only, home, inpatient, emergency department, or procedure-only encounters without an in-office visit.
- If any image data captured on the patient were known to have been used for training or validating DEXI.
Where
- Stanford, California
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Collaborators
National Institutes of Health (NIH), Canfield Scientific Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 22, 2026 · Source of record for eligibility and locations