Accuracy of Lucid’s In-Vivo Confocal Imaging to be Evaluated for Pigmented Lesion Diagnosis Under NCI Grant
March 15, 2007 (PRLEAP.COM) Health NewsROCHESTER, NEW YORK, USA, March 15, 2007 – Lucid, Inc. has received a $1.9 million, 3-year grant from the National Institute of Health’s (NIH) National Cancer Institute (NCI) to perform a large clinical study to evaluate the efficacy of its VivaScope® in-vivo confocal microscopy technology for the diagnosis of pigmented lesions.
The study is being conducted at 5 sites including: Memorial Sloan Kettering Cancer Center’s facilities in New York City and Long Island; the University of Rochester Medical Center in Rochester, New York; and the Loma Linda University in Loma Linda, California. The study will involve approximately 600 patients presenting a suspicious pigmented lesion on clinical examination.
“The need for early detection is crucial to a melanoma patient's long-term survival of this disease,” said Jay Eastman, chairman and CEO of Lucid, Inc. “This grant represents one of the steps required to bring a revolutionary medical device to the market that combines early detection capabilities with a painless, non-surgical procedure.”
Lucid’s VivaScope confocal microscopy can non-invasively image skin in-vivo with cellular resolution. This potentially permits pathologic diagnosis without the need to excise tissue. “Just as MRI and CT scans have largely eliminated the need for routine ‘exploratory surgery’, in-vivo reflectance confocal microscopy may one day eliminate the need for routine invasive skin biopsy.”
The clinical research plan is intended to demonstrate the efficacy of Lucid’s VivaScope digital imaging technology. In addition, the clinical investigators involved in the project intend to produce and submit for publication an extensive atlas of confocal images and a glossary of terms for the description of confocal images of pigmented lesions. Presently, study protocols are under development for submission to the participating medical centers’ Institutional Review Boards. The project will be completed within two years from now.
The American Cancer Society estimated that in 2006, 62,190 new cases of invasive melanoma were diagnosed in the United States, and that 7,910 deaths occurred due to the disease. According to Cancer Facts and Figures 2005, if melanoma is diagnosed and removed while the tumor is localized, the 5-year survival rate is 97.6%; however if the lesion has metastasized to either a regional or distant site, the five-year survival rate drops to 60.3% or 16.2%, respectively.
Pilot studies of the efficacy of confocal imaging for the diagnosis of melanoma, published in 2004 - 2006, demonstrated high sensitivity and specificity for VivaScope images read by a panel of diagnostic readers with relatively little training (30 to 60 minutes) in confocal image interpretation.
This new study, a comparison of confocal imaging to the "gold standard" of pathologic examination of excised tissues, will be conducted at leading U.S. clinical sites and will utilize well-trained diagnostic readers,” said Eastman. “It should produce compelling clinical data for use in the Federal regulatory approval process. We believe the project has a high probability of a positive outcome,” he said.
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About Lucid, Inc.
Lucid Inc., based in Rochester, New York, is a medical device and information company dedicated to creating innovative cellular imaging technology and using the Internet to securely deliver accurate, real-time VivaScope® cellular resolution images to medical professionals. When coupled with its digital VivaNetTM system, the company’s ability to image in-vivo (living) tissue will aid medical practitioners and pathologists in skin cancer screening with clarity, speed and patient comfort. For more information, visit www.Lucid-tech.com.