Large Blinded Clinical Study Achieves High Accuracy for the Diagnosis of Melanoma Using In Vivo Confocal Microscopy

Wednesday, September 19, 2007 General News
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ROCHESTER, N.Y., Sept. 18 A landmark publication thatappeared in the Journal of Investigative Dermatology reports the results of alarge, two site blinded clinical study. The paper is entitled "The Impact ofIn Vivo Reflectance Confocal Microscopy for the Diagnostic Accuracy ofMelanoma and Equivocal Melanocytic Lesions."

The study, lead by Dr. Giovanni Pellacani, contained a total of 351equivocal melanocytic lesions that were difficult for expert dermoscopists todiagnose. 136 of the 351 lesions were malignant melanomas. The highestsensitivity demonstrated by confocal microscopy was 96.3%. The highestaccuracy 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 thedecision-making process faced by dermatologists examining melanocyticlesions," said Dr. Giovanni Pellacani, Department of Dermatology, Universityof Modena and Reggio Emilia, Modena, Italy, one of the world's leading in-vivoconfocal imaging medical researchers. "Consequently, in vivo confocalmicroscopy is used at Modena and in several other melanoma clinics in Europefor the analysis of melanocytic lesions," Dr. Pellacani continued.

Images Acquired from Lucid VivaScopes(R) in 5 to 10 minutes

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

Study Detailed in the Journal of Investigative Dermatology

The entire paper recounting the study can be found in the Journal ofInvestigative Dermatology (2007), 0, 000-000, doi: 10.1038/sj.jid.5700993,"The Impact of In Vivo Reflectance Confocal Microscopy for the DiagnosticAccuracy of Melanoma and Equivocal Melanocytic Lesions," authors GiovanniPellacani, Pascale Guitera, Caterina Longo, Michelle Avramidis, StefaniaSeidenari and Scott Menzies. On the Web, visit .

Authors Pellacani, Longo, and Seidenari are of the Department ofDermatology, University of Modena and Reggio Emilia, Modena, Italy. Guitera,Avramidis, and Menzies are of the Faculty of Medicine, Sydney MelanomaDiagnostic Centre, Sydney Cancer Centre and Dermatology Department, RoyalPrince Alfred Hospital, University of Sydney, Sydney, Australia.

This paper builds on the results of an earlier pilot study that waspublished in the December 2005 issue of the Journal of the American Academy ofDermatology, beginning on page 979 of that issue.

About Lucid Inc.

Lucid Inc., based in Rochester, New York, USA, is a medical device andinformation company dedicated to creating innovative cellular imagingtechnology and using the Internet to securely deliver accurate, real-timeVivaScope(R) cellular resolution images to medical professionals. Whencoupled with its digital VivaNet(TM) system, the company's ability to imagein-vivo (living) tissue will aid medical practitioners and pathologists inskin cancer screening with clarity, speed and patient comfort. For moreinformation about Lucid Inc., visit .Available Topic Expert(s): For information on the listed expert(s), clickappropriate link.Jay Eastman, Ph.D.

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