The purpose of this clinical trial is to demonstrate that MelaFind®, a new instrument that uses machine vision for non-invasive early detection of cutaneous pigmented malignant melanoma, is safe and effective. MelaFind® acquires digital images of the lesion with illumination in different spectral bands, from visible to near infrared, and automatically analyzes these images. Diagnostic accuracy of MelaFind® and that of study dermatologists will be evaluated. The reference standard will be final interpretation of lesions by central dermatohistopathology.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,383
Biopsy ratio comparison
Skin and Cancer Associates
Plantation, Florida, United States
Dermatology Associates of Tallahassee
Tallahassee, Florida, United States
Sensitivity and Specificity
Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.
Time frame: Within 120 days of Data Lock
Biopsy Ratio
Number of lesions bioopsied to melanomas detected
Time frame: Within 120 days of Data Lock
Exploratory Analyses
Time frame: Within 365 days of Data Lock
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