The performance of MelaFind: a prospective multicenter study.
OBJECTIVE
To demonstrate the safety and effectiveness of MelaFind, a noninvasive and objective computer-vision system designed to aid in detection of early pigmented cutaneous melanoma.


METHODS
A prospective, multicenter, blinded study. The diagnostic performance of MelaFind and of study clinicians was evaluated using the histologic reference standard. Standard images and patient information for a subset of 50 randomly selected lesions (25 melanomas) were used in a reader study of 39 independent dermatologists to estimate clinicians' biopsy sensitivity to melanoma.


METHODS
Three academic and 4 community practices in the United States with expertise in management of pigmented skin lesions.


METHODS
A total of 1383 patients with 1831 lesions enrolled from January 2007 to July 2008; 1632 lesions (including 127 melanomas-45% in situ-with median Breslow thickness of invasive lesions, 0.36 mm) were eligible and evaluable for the study end points.


METHODS
Sensitivity of MelaFind; specificities and biopsy ratios for MelaFind and the study investigators; and biopsy sensitivities of independent dermatologists in the reader study.


RESULTS
The measured sensitivity of MelaFind was 98.4% (125 of 127 melanomas) with a 95% lower confidence bound at 95.6% and a biopsy ratio of 10.8:1; the average biopsy sensitivity of dermatologists was 78% in the reader study. Including borderline lesions (high-grade dysplastic nevi, atypical melanocytic proliferations, or hyperplasias), MelaFind's sensitivity was 98.3% (172 of 175), with a biopsy ratio of 7.6:1. On lesions biopsied mostly to rule out melanoma, MelaFind's average specificity (9.9%) was superior to that of clinicians (3.7%) (P=.02).


CONCLUSIONS
MelaFind is a safe and effective tool to assist in the evaluation of pigmented skin lesions.


BACKGROUND
clinicaltrials.gov Identifier: NCT00434057.
Monheit
Gary
G
Total Skin and Beauty Dermatology, Birmingham, Alabama, USA.
Cognetta
Armand B
AB
Ferris
Laura
L
Rabinovitz
Harold
H
Gross
Kenneth
K
Martini
Mary
M
Grichnik
James M
JM
Mihm
Martin
M
Prieto
Victor G
VG
Googe
Paul
P
King
Roy
R
Toledano
Alicia
A
Kabelev
Nikolai
N
Wojton
Maciej
M
Gutkowicz-Krusin
Dina
D
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D002648:Child; D005260:Female; D006801:Humans; D007090:Image Interpretation, Computer-Assisted / Q000295:instrumentation*; D008297:Male; D008545:Melanoma / Q000175:diagnosis*; D008875:Middle Aged; D010858:Pigmentation; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D012878:Skin Neoplasms / Q000175:diagnosis*; D055815:Young Adult