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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-24

Study Completion Date

2022-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Skin Lesion Melanoma (Skin) Mole

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspicious Nevi undergoing biopsy

Subject with suspicious Nevi undergoing biopsy per SOC

Diagnostic Test

Intervention Type OTHER

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

Interventions

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Diagnostic Test

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

Intervention Type OTHER

Other Intervention Names

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SFI 001 Imaging

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No