The performance of MelaFind: A prospective multicenter study

Gary Monheit, Armand B. Cognetta, Laura Ferris, Harold Rabinovitz, Kenneth Gross, Mary Martini, James M. Grichnik, Martin Mihm, Victor G. Prieto, Paul Googe, Roy King, Alicia Toledano, Nikolai Kabelev, Maciej Wojton, Dina Gutkowicz-Krusin

Research output: Contribution to journalArticle

145 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)188-194
Number of pages7
JournalArchives of dermatology
Volume147
Issue number2
DOIs
StatePublished - Feb 1 2011

ASJC Scopus subject areas

  • Dermatology

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    Monheit, G., Cognetta, A. B., Ferris, L., Rabinovitz, H., Gross, K., Martini, M., Grichnik, J. M., Mihm, M., Prieto, V. G., Googe, P., King, R., Toledano, A., Kabelev, N., Wojton, M., & Gutkowicz-Krusin, D. (2011). The performance of MelaFind: A prospective multicenter study. Archives of dermatology, 147(2), 188-194. https://doi.org/10.1001/archdermatol.2010.302