Clinical Trial: In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: In Vivo Reflectance Confocal Microscopy for Pigmented Lesion Diagnosis: A Multi-center Study
Brief Summary:
The purpose of this study is to image pigmented skin lesions suspicious for melanoma with an imaging technology called in vivo reflectance confocal microscopy. This technology uses low intensity laser to image below the surface of the skin. The confocal images of the suspicious skin lesion will be examined. The goal of this study is to compare the results of the confocal image examination to the pathologic diagnosis of the skin lesion.
The technique being evaluated in this study uses reflectance confocal microscopy in vivo. The term "in vivo" means in/on a living subject. In this study you will be the living subject and the confocal microscope will be placed on your skin to look at your skin lesion. The confocal microscope uses a weak laser light and a sophisticated lens to image the individual cells that make up the skin. Your lesion will be photographed with high resolution photography.
Detailed Summary:
Patients will be imaged with the VivaScope 1500 reflectance confocal microscope during a single patient visit. The lesion will be photographed with high resolution photography and a high resolution dermoscopic device.
The lesion will then be prepared for RCM imaging. A skin contact device consisting of a metal ring and window will be applied to the skin surrounding the lesion of interest with a disposable medical grade adhesive. A wetting solution will be placed onto the skin. The wetting solutions include a high index oil such as a clear cosmetic oil or mineral oil. A wetting solution such as ultrasound gel will also be placed on the lens of the microscope. Application of these agents diminishes artifacts caused by light scattering at the skin surface. RCM images of the lesion will be captured through the window/contact device using the Vivascope 1500 reflectance confocal microscope provided by Lucid, Inc. Two types of images will be collected, mosaics and stacks. Mosaics are 12x12 confocal images that are optically combined or "stitched" together to create a seamless representation of a 6mm x 6mm total area at specific depths within the skin. Stacks are 0.5mm x 0.5mm confocal images taken at 5 micron intervals from the keratin layer to the superficial dermis. Mosaics and stacks will be acquired for the skin lesion. The total estimated imaging time for a patient in this study is about 10 minutes for each lesion. More than one lesion may be imaged per patient.
After the imaging is complete, the lesion will be biopsied. All lesion images will be saved on a network server for later review and analysis. All imaging will be completed by trained research staff familiar with confocal imaging.
Sponsor: Lucid, Inc.
Current Primary Outcome: To assess the diagnostic accuracy of reflectance confocal scanning laser microscopy(RCM) for melanoma diagnosis when compared to the "gold standard" histopathologic diagnosis. [ Time Frame: Once while on study ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To assess interobserver variability associated with interpreting confocal images for detecting cutaneous melanoma and to assess confocal correlations in a qualitative manner. [ Time Frame: Once while on study ]
Original Secondary Outcome: Same as current
Information By: Lucid, Inc.
Dates:
Date Received: November 4, 2008
Date Started: August 2008
Date Completion:
Last Updated: October 2, 2012
Last Verified: October 2012
