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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03535077

Enrollment

186

Registered

2018-05-24

Start date

2018-01-24

Completion date

2022-12-31

Last updated

2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin), Mole, Skin Lesion

Keywords

Melanoma, Nevus, Mole, Atypical Nevi

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

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.

Interventions

OTHERDiagnostic Test

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026