Recruiting
Phase 3

DEXI

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07890415

Conditions

Malignant Melanoma of Skin

Other and Unspecified Malignant Neoplasm of Skin

Melanoma in Situ

Carcinoma in Situ of Skin

Hemangioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clinical decision support tool

Study Details

Brief summary:

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.

Conditions

Malignant Melanoma of Skin

Other and Unspecified Malignant Neoplasm of Skin

Melanoma in Situ

Carcinoma in Situ of Skin

Hemangioma

Study ID

NCT07890415

Start date

Oct 15, 2026

Status verified date

Oct, 2026

Completion date

Oct 15, 2029

Anticipated

Primary completion date

Oct 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

14000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Investigational Visit

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

no intervention: Control Visit

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

Interventions

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 measure

  • Overall melanoma detection rate per visit [ Time Frame: up to 4 years ]

Central Contacts and Locations

Central contacts

Veronica Rotemberg, MD

646-608-2367rotembev@mskcc.org

Ashfaq Marghoob, MD

631-863-5121marghooa@MSKCC.ORG

Locations

Memorial Sloan Kettering at Basking Ridge (All protocol activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Veronica Rotemberg, MD

646-608-2367

Memorial Sloan Kettering Monmouth (Consent only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Veronica Rotemberg, MD

646-608-2367

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Veronica Rotemberg, MD

646-608-2367

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)

Recruiting

Commack, New York, United States, 11725

Contacts

Veronica Rotemberg, MD

646-608-2367

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Veronica Rotemberg, MD

646-608-2367

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Veronica Rotemberg, MD

646-608-2367

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Veronica Rotemberg, MD

646-608-2367

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • Malignant melanoma of skin
  • Other and unspecified malignant neoplasm of skin
  • Melanoma in situ
  • Carcinoma in situ of skin
  • Hemangioma
  • Melanocytic nevi
  • Other benign neoplasms of skin
  • Neoplasm of uncertain behavior of skin
  • Neoplasm of uncertain behavior, unspecified
  • Neoplasm of unspecified behavior of bone, soft tissue, and skin
  • Nevus, non-neoplastic
  • Skin changes due to chronic exposure to nonionizing radiation
  • Other specified follicular disorders
  • Other melanin hyperpigmentation
  • Seborrheic keratosis
  • Congenital non-neoplastic nevus
  • Memorial Sloan Kettering Cancer Center
  • 26-209

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.