Assessing Tissue Remodeling in the Skin Using SFI (Skin Fluorescence Imaging)

Assessing Tissue Remodeling in the Skin Using Skin Fluorescence Imaging (SFI)

The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin

Study Overview

• Status: Completed
• Conditions: Skin Lesion; Melanoma (Skin); Mole
• Intervention / Treatment: Other: Diagnostic Test

Detailed Description

The goal of the SFI is to provide non-invasive information about tissue remodeling occurring during melanocytic transition and atypia development in the skin. SFI analyzes the topical staining of the skin surface using the ORL-1 dye to reveal the presence of remodeling in the skin, together with the visible feature characteristics. The system provides a biometric score corresponding to the dye staining, a structural score, and a composite SFI score to quantify the presence of tissue remodeling and the process of melanocytic transition in the skin.

• Study Type: Observational
• Enrollment (Actual): 186

Contacts and Locations

• Study Contact: Name: Brandi Dunn Project Manager, RN; Phone Number: 2107714024; Email: brandi.dunn@orlucent.com

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Center For Dermatology Clinical Research, Inc
    • Irvine, California, United States, 92697
      • UCI Center for Clinical Research
    • Menlo Park, California, United States, 94025
      • Divya Railan, Md, Faad
    • Northridge, California, United States, 91324
      • Quest Dermatology Research
    • Vallejo, California, United States, 94590
      • Solano Dermatology Associates
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study will enroll subjects being evaluated for suspicious moles/nevi and who will be scheduled to undergo a biopsy of the mole/nevus as part of the physicians standard plan of care.

Description

Inclusion Criteria:

1. Subjects with a pigmented skin lesion recommended for a skin biopsy.
2. A lesion that is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
3. At least 21 years old.
4. Written, signed, and dated informed consent
5. Scheduled for a primary excision/biopsy as part of the clinics SOC.

Exclusion Criteria:

1. Lesion is less than 1 centimeter from the eyes.
2. Lesion is on the palms of the hands or soles of the feet.
3. Mucosal lesion.
4. Ulcerated lesion.
5. Subject is pregnant or planning to become pregnant during the study period.
6. Patients who are mentally or physically unable to comply with all aspects of the study.
7. Any subject undergoing chemotherapy.
8. Any lesion that has been treated with local anesthesia such as lidocaine prior to enrollment that would confound study results.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspicious Nevi undergoing biopsy; Subject with suspicious Nevi undergoing biopsy per SOC	Other: Diagnostic Test; Imaging of the suspicious lesion after application of ORL-1 dye prior to biopsy; Other Names: SFI 001 Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation	To identify histological features that correlate with the imaging features captured using SFI	1 day

Collaborators and Investigators

• Sponsor: Orlucent, Inc
• Investigators: Study Director: Cathy Shachaf, PhD, President

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: May 12, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Melanoma; Nevus; Atypical Nevi; Mole
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: SFI 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No