Clinical Study Achieves High Accuracy For Diagnosis Of Melanoma

Melanoma

A landmark publication that appeared in the Journal of Investigative Dermatology reports the results of a large, two site blinded clinical study. The paper is entitled "The Impact of In Vivo Reflectance Confocal Microscopy for the Diagnostic Accuracy of Melanoma and Equivocal Melanocytic Lesions."

The study, lead by Dr. Giovanni Pellacani, contained a total of 351 equivocal melanocytic lesions that were difficult for expert dermoscopists to diagnose. 136 of the 351 lesions were malignant melanomas. The highest sensitivity demonstrated by confocal microscopy was 96.3%. The highest accuracy corresponded to a sensitivity of 91.9% and a specificity of 69.3%. The standard of comparison for the study was biopsy of all 351 lesions, followed by traditional pathological examination.

"By giving reliable diagnostic information comparable to histology, confocal imaging represents the only feasible alternative to biopsy in the decision-making process faced by dermatologists examining melanocytic lesions," said Dr. Giovanni Pellacani, Department of Dermatology, University of Modena and Reggio Emilia, Modena, Italy, one of the world's leading in-vivo confocal imaging medical researchers. "Consequently, in vivo confocal microscopy is used at Modena and in several other melanoma clinics in Europe for the analysis of melanocytic lesions," Dr. Pellacan continued.

Images Acquired from Lucid VivaScopes in 5 to 10 minutes

"The images in this study were acquired using VivaScope confocal microscopes developed and manufactured by Lucid Inc., of Rochester, New York," said Jay Eastman, Ph.D., Chairman and CEO of Lucid, Inc. "This study represents a major clinical milestone in the transition of confocal imaging from a basic research tool to a diagnostic medical device being used routinely for evaluation of melanocytic lesions. Imaging a single lesion using the VivaScope required just 5 to 10 minutes according to the authors," continued Eastman, "which makes it practical for everyday use in private dermatology practices worldwide."