In Vivo Reflectance Confocal Microscopy for Pigmented Lesion Diagnosis: A Multi-center Study
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
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To assess the diagnostic accuracy of reflectance confocal scanning laser microscopy(RCM) for melanoma diagnosis when compared to the "gold standard" histopathologic diagnosis.
Once while on study
Allan C Halpern, MD
Memorial Sloan-Kettering Cancer Center, Manhattan
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Rochester Medical Center||Rochester, New York 14642|
|Loma Linda University||Loma Linda, California 92354|
|VA Loma Linda Health Care System||Loma Linda, California 92357|
|Skin and Cancer Assoicates||Plantation, Florida 33324|