Using an Artificial Intelligence (AI) Tool for Melanoma Diagnosis

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 3

Conditions: Melanocytic Nevi; Malignant Melanoma of Skin; Melanoma in Situ; Other Specified Follicular Disorders; Skin Changes Due to Chronic Exposure to Nonionizing Radiation; Carcinoma in Situ of Skin; Neoplasm of Uncertain Behavior, Unspecified; Hemangioma; Congenital Non-Neoplastic Naevus; Other Melanin Hyperpigmentation; Neoplasm of Unspecified Behavior of Bone, Soft Tissue, and Skin; Other Benign Neoplasms of Skin; Other and Unspecified Malignant Neoplasm of Skin; Nevus, Non-Neoplastic; Seborrheic Keratosis; Neoplasm of Uncertain Behavior of Skin

Treatments: Diagnostic Test: Clinical decision support tool

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07890415

26-209

1R01CA293974-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

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. 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.

Enrollment: 14,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14,000 participants in 2 patient groups

Investigational Visit

Experimental group

Description:

Clinical decision support/CDS available to investigative providers; CDS may or may not be used at a given dermatology visit

Treatment:

Diagnostic Test: Clinical decision support tool

Control Visit

No Intervention group

Description:

Clinical decision support/CDS unavailable (technically disabled); Standard of care/SOC skin examination.