Skin Fluorescent Imaging (SFI) System in Patients With Nevi

Nevus Clinical Trial

Official title:

Skin Fluorescent Imaging (SFI) System in Patients With Nevi

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04368247
• Other study ID #: SFI 003
• Status: Recruiting
• Start date: August 10, 2020
• Est. completion date: August 2021

Study information

• Verified date: November 2020
• Source: Orlucent, Inc
• Contact: BRANDI DUNN
• Phone: 2107714024
• Email: brandi.dunn[@]orlucent.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2021
• Est. primary completion date: June 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysplasia; Epithelial
• Nevus

Intervention

Diagnostic Test:
• Skin Fluorescent Imaging
Application of reagents, then imaging and scoring

Locations

Country	Name	City	State
United States	Center for Dermatology Clinical Research, Inc	Fremont	California
United States	Quest Dermatology Research	Northridge	California
United States	University of Utah	Salt Lake City	Utah
United States	Solano Dermatology Associates	Vallejo	California

Sponsors (1)

Lead Sponsor	Collaborator
Orlucent, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the performance of SFI	Establish the performance (sensitivity and specificity) for SFI in comparison to dysplasia.	1year
Secondary	To compare SFI to clinical diagnosis.	Comparison of the SFI score ( 0 to 10) to the clinical diagnosis of the physician assessing and the pathologist	1 year
Secondary	To establish the tolerability of SFI Testing by documenting minimal, transient events that occur with reagent application.	Adverse events will be collected to ensure overall safety of reagents and imaging	1 year