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Skin Fluorescent Imaging (SFI) System in Patients With Nevi

Sponsor
Orlucent, Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04368247
Collaborator
(none)
300
Enrollment
4
Locations
11.7
Anticipated Duration (Months)
75
Patients Per Site
6.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Skin Fluorescent Imaging

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Skin Fluorescent Imaging (SFI) System in Patients With Nevi
Actual Study Start Date :
Aug 10, 2020
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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
Application of reagents, then imaging and scoring
Other Names:
  • SFI 003 Imaging

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Establish the performance of SFI [1year]

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

    Secondary Outcome Measures

    1. To compare SFI to clinical diagnosis. [1 year]

      Comparison of the SFI score ( 0 to 10) to the clinical diagnosis of the physician assessing and the pathologist

    2. To establish the tolerability of SFI Testing by documenting minimal, transient events that occur with reagent application. [1 year]

      Adverse events will be collected to ensure overall safety of reagents and imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Dermatology Clinical Research, Inc Fremont California United States 94538
    2 Quest Dermatology Research Northridge California United States 91324
    3 Solano Dermatology Associates Vallejo California United States 94590
    4 University of Utah Salt Lake City Utah United States 84112

    Sponsors and Collaborators

    • Orlucent, Inc

    Investigators

    • Study Director: Cathy Shachaf, PhD, President

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Orlucent, Inc
    ClinicalTrials.gov Identifier:
    NCT04368247
    Other Study ID Numbers:
    • SFI 003
    First Posted:
    Apr 29, 2020
    Last Update Posted:
    Nov 19, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Orlucent, Inc
    Nevus
    Atypical Nevi
    Mole
    Skin Imaging
    Additional relevant MeSH terms:
    Nevus

    Study Results

    No Results Posted as of Nov 19, 2020