TY - JOUR
T1 - The performance of MelaFind
T2 - A prospective multicenter study
AU - Monheit, Gary
AU - Cognetta, Armand B.
AU - Ferris, Laura
AU - Rabinovitz, Harold
AU - Gross, Kenneth
AU - Martini, Mary
AU - Grichnik, James M.
AU - Mihm, Martin
AU - Prieto, Victor G.
AU - Googe, Paul
AU - King, Roy
AU - Toledano, Alicia
AU - Kabelev, Nikolai
AU - Wojton, Maciej
AU - Gutkowicz-Krusin, Dina
N1 - Copyright:
Copyright 2011 Elsevier B.V., All rights reserved.
PY - 2011/2
Y1 - 2011/2
N2 - Objective: To demonstrate the safety and effectiveness of MelaFind, a noninvasive and objective computervision system designed to aid in detection of early pigmented cutaneous melanoma. Design: 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. Setting: Three academic and 4 community practices in the United States with expertise in management of pigmented skin lesions. Patients: 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. Main Outcome Measures: 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). Conclusion: MelaFind is a safe and effective tool to assist in the evaluation of pigmented skin lesions. Trial Registration: clinicaltrials.gov Identifier: NCT00434057.
AB - Objective: To demonstrate the safety and effectiveness of MelaFind, a noninvasive and objective computervision system designed to aid in detection of early pigmented cutaneous melanoma. Design: 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. Setting: Three academic and 4 community practices in the United States with expertise in management of pigmented skin lesions. Patients: 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. Main Outcome Measures: 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). Conclusion: MelaFind is a safe and effective tool to assist in the evaluation of pigmented skin lesions. Trial Registration: clinicaltrials.gov Identifier: NCT00434057.
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U2 - 10.1001/archdermatol.2010.302
DO - 10.1001/archdermatol.2010.302
M3 - Article
C2 - 20956633
AN - SCOPUS:79951998812
SN - 0003-987X
VL - 147
SP - 188
EP - 194
JO - Archives of Dermatology
JF - Archives of Dermatology
IS - 2
ER -