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

Orlucent

Status: Completed

Conditions: Mole; Melanoma (Skin); Skin Lesion

Treatments: Other: Diagnostic Test

Study type: Observational

Funder types: Industry

Identifiers

NCT03535077

SFI 001

Details and patient eligibility

About

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

Full 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.

Enrollment: 186 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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.

Trial design

186 participants in 1 patient group

Suspicious Nevi undergoing biopsy

Description:

Subject with suspicious Nevi undergoing biopsy per SOC

Treatment:

Other: Diagnostic Test