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

NCT03535077 | Completed DMC

• 1 other identifier: SFI 001
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Skin Lesion; Melanoma (Skin); Mole

Keywords

Melanoma; Nevus; Mole; Atypical Nevi

Outcome Measures

Primary Outcomes (1)

• Correlation

  To identify histological features that correlate with the imaging features captured using SFI

  1 day

Study Arms (1)

Suspicious Nevi undergoing biopsy

Subject with suspicious Nevi undergoing biopsy per SOC

Other: Diagnostic Test

Interventions

Diagnostic Test OTHER

Imaging of the suspicious lesion after application of ORL-1 dye prior to biopsy

Also known as: SFI 001 Imaging

Suspicious Nevi undergoing biopsy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects with a pigmented skin lesion recommended for a skin biopsy.
• 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.
• At least 21 years old.
• Written, signed, and dated informed consent
• Scheduled for a primary excision/biopsy as part of the clinics SOC.

You may not qualify if:

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

Sponsors & Collaborators

• Orlucent, Inc: lead

Study Sites (6)

Center for Dermatology Clinical Research, Inc

Fremont, California, 94538, United States

Location

UCI Center for Clinical Research

Irvine, California, 92697, United States

Location

Divya Railan, Md, Faad

Menlo Park, California, 94025, 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

MeSH Terms

Conditions

Melanoma; Nevus; Dysplastic Nevus Syndrome

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; 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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: May 24, 2018
• Study Start: January 24, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)