Skin Fluorescent Imaging (SFI) System in Patients With Nevi

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.

• Skin Fluorescent Imaging (Diagnostic test), also known as SFI 003 Imaging: Application of reagents, then imaging and scoring

Primary outcomes

• Establish the performance of SFI [1year]: Establish the performance (sensitivity and specificity) for SFI in comparison to dysplasia.

Secondary outcomes

• To compare SFI to clinical diagnosis. [1 year]: Comparison of the SFI score ( 0 to 10) to the clinical diagnosis of the physician assessing and the pathologist
• To establish the tolerability of SFI Testing by documenting minimal, transient events that occur with reagent application. [1 year]: Adverse events will be collected to ensure overall safety of reagents and imaging

Sex: All, ages: 18 Years to any

Inclusion Criteria:

In order to be eligible to participate in this study a subject must meet all of the following criteria:

* Provide a signed and dated informed consent form
* Age ≥ 18 years old
* Subjects must present with suspicious atypical nevi scheduled for a biopsy*
* Nevi with at least 1 cm of skin surrounding the mole
* Nevi must be accessible to the SFI imaging device
* Excisional or a tangential excision with a dept of 1 to 2 mm biopsy will be performed for the mole tested within 21 days of testing.
* Nevi with clinically atypical features

Only 1 mole per eligible subject will be SFI tested in this study. *NOTE: a subset of patients (\~10%) with benign nevi (by clinical observation) who wish to have nevi removed for cosmetic reasons will be enrolled as negative controls.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Subjects who are younger than 18 years old
* Lesions that are consistent with

  \- Features of Keratosis and keratin plugs
  * Basal Cell Carcinoma
  * Squamous Cell Carcinoma
  * Challenging anatomical location (e.g., body cervices)
* Subjects with nevi that fit the inclusion criteria but are:

  * Less than 1 cm from the eyes
  * On the palms of the hands or soles of the feet
  * Associated with scar tissue
  * Mucosal lesions
  * Ulcerated lesions / breached skin
  * Lesions with some clinical certainty of being melanomas (large, dark, etc.)
  * Any nevi with ink marking including tattoos, on or adjacent to the nevi
  * Lesions treated with local anesthesia such as lidocaine prior to enrollment
  * Lesions larger than 20 mm or too large to allow imaging
  * Subject is known to be pregnant
  * Subject who is mentally or physically unable to comply with all aspects of the study
  * Subject who is undergoing systemic cancer treatment within 6 months of SFI testing
  * Subject with hypersensitivity to any of the SFI reagents
  * Subjects with known sensitivity to fluorescent dyes
  * Any subject who has previously participated (testing to biopsy) in SFI 003

• Cathy Shachaf, PhD, Study director, President