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.
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: June 2021
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.
- Diagnostic Test: Skin Fluorescent Imaging
- Application of reagents, then imaging and scoring
Arms, Groups and Cohorts
- Nevi undergoing biopsy per SOC
- Subjects with Nevi who will as part of their standard of care, will undergo biopsy.
Clinical Trial Outcome Measures
- Establish the performance of SFI
- Time Frame: 1year
- Establish the performance (sensitivity and specificity) for SFI in comparison to dysplasia.
- To compare SFI to clinical diagnosis.
- Time Frame: 1 year
- Comparison of the SFI score to the clinical diagnosis of the physician assessing and the pathologist
- To establish the safety of SFI.
- Time Frame: 1 year
- Adverse events will be collected to ensure overall safety of reagents and imaging
Participating in This Clinical Trial
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
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
- Lead Sponsor
- Orlucent, Inc
- Provider of Information About this Clinical Study
- Overall Official(s)
- Cathy Shachaf, PhD, Study Director, President
- Overall Contact(s)
- BRANDI DUNN, 2107714024, firstname.lastname@example.org
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