Melanoma Clinical Trial
Skin Fluorescent Imaging (SFI) System in Patients With Nevi
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.
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.
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
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
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There are 4 Locations for this study
Fremont California, 94538, United States More Info
Northridge California, 91324, United States More Info
Vallejo California, 94590, United States More Info
Salt Lake City Utah, 84112, United States More Info
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