Skin Fluorescent Imaging (SFI) System in Patients With Nevi

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