Skin Fluorescent Imaging (SFI) System in Patients With Nevi

NCT04368247 | Completed FDA Device

• 1 other identifier: SFI 003
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

Nevus; Dysplasia; Epithelial

Keywords

Nevus; Atypical Nevi; Mole; Skin Imaging

Outcome Measures

Primary Outcomes (1)

• Establish the performance of SFI

  Establish the performance (sensitivity and specificity) for SFI in comparison to dysplasia.

  1year

Secondary Outcomes (2)

• To compare SFI to clinical diagnosis.

  1 year

• To establish the tolerability of SFI Testing by documenting minimal, transient events that occur with reagent application.

  1 year

Study Arms (1)

Nevi undergoing biopsy per SOC

Subjects with Nevi who will as part of their standard of care, will undergo biopsy.

Diagnostic Test: Skin Fluorescent Imaging

Interventions

Skin Fluorescent Imaging DIAGNOSTIC_TEST

Application of reagents, then imaging and scoring

Also known as: SFI 003 Imaging

Nevi undergoing biopsy per SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Orlucent, Inc: lead

Study Sites (4)

Center for Dermatology Clinical Research, Inc

Fremont, California, 94538, United States

Location

Quest Dermatology Research

Northridge, California, 91324, United States

Location

Solano Dermatology Associates

Vallejo, California, 94590, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

If the Site specific pathology lab will not allow the sponsor to make a digital image of the original slide, then the Sponsor is asking that a duplicate slide be provided for digital scanning. Once scanning is complete these additional slides may not be returned to the site.

MeSH Terms

Conditions

Nevus; Carcinoma in Situ; Dysplastic Nevus Syndrome

Condition Hierarchy (Ancestors)

Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Cathy Shachaf, PhD

  President

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 29, 2020
• Study Start: August 10, 2020
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2023
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

US (4)