Clinical trial NCT04368247: Skin Fluorescent Imaging (SFI) System in Patients With Nevi
Official title: Skin Fluorescent Imaging (SFI) System in Patients With Nevi
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nevus
Dysplasia; Epithelial
Keywords: Nevus
Atypical Nevi
Mole
Skin Imaging
Lead sponsor: Orlucent, Inc
Sponsor class: INDUSTRY
First posted: 2020-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who present with suspicious nevus/nevi and who require a Standard of Care (SOC) biopsy of the atypical nevi will be able to participate in the study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Establish the performance of SFI
timeFrame: 1year
Secondary outcomes:
measure: To compare SFI to clinical diagnosis.
timeFrame: 1 year
measure: To establish the tolerability of SFI Testing by documenting minimal, transient events that occur with reagent application.
timeFrame: 1 year
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc
state: California
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: Vallejo
country: United States
facility: Solano Dermatology Associates
state: California
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: President
name: Cathy Shachaf, PhD
role: STUDY_DIRECTOR
References: