The Sponsor has developed the Skin Fluorescent Imaging (SFI) system, an in vivo imaging modality, for the purpose of providing physicians with insight into the biological changes occurring during tissue remodeling in a nevus.
The SFI system, a non-invasive point-of-care imaging system, is able to detect markers associated with tissue remodeling and thus provide real-time information about biological and structural changes occurring in nevi indicative of dysplastic transition.
Study Type
OBSERVATIONAL
Enrollment
300
Application of reagents, then imaging and scoring
Center for Dermatology Clinical Research, Inc
Fremont, California, United States
Quest Dermatology Research
Northridge, California, United States
Solano Dermatology Associates
Vallejo, California, United States
University of Utah
Salt Lake City, Utah, United States
Establish the performance of SFI
Establish the performance (sensitivity and specificity) for SFI in comparison to dysplasia.
Time frame: 1year
To compare SFI to clinical diagnosis.
Comparison of the SFI score ( 0 to 10) to the clinical diagnosis of the physician assessing and the pathologist
Time frame: 1 year
To establish the tolerability of SFI Testing by documenting minimal, transient events that occur with reagent application.
Adverse events will be collected to ensure overall safety of reagents and imaging
Time frame: 1 year
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