Melanoma Clinical Trial

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

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

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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.

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Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Melanoma

Estimated Enrollment:

186

Study ID:

NCT03535077

Recruitment Status:

Completed

Sponsor:

Orlucent, Inc

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There are 6 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

186

Study ID:

NCT03535077

Recruitment Status:

Completed

Sponsor:


Orlucent, Inc

How clear is this clinincal trial information?

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