NCT07890415RecruitingPhase 3
Using an Artificial Intelligence (AI) Tool for Melanoma Diagnosis
Pragmatic Randomized Controlled Trial of Artificial Intelligence for Melanoma Diagnosis (PRACTA-MEL) (AI)
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 14000 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- 15 Oct 2026
- Primary completion date
- 15 Oct 2029
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Melanoma
- NCT number
- NCT07890415
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 14000
- From 15 Oct 2026 to the primary completion date, 15 Oct 2029
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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:
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only) Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| Memorial Sloan Kettering Westchester (All Protocol Activities) Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| Memorial Sloan Kettering Monmouth (Consent Only) Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| Memorial Sloan Kettering Bergen (Consent Only) Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center (All Protocol Activites) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Stanford University (Data Collection Only) Coordinator of this site? Confirm its status | Stanford | United States | Not yet recruiting |
| Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) Coordinator of this site? Confirm its status | Uniondale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.