Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging

Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System)

The use of MDS to access the presence of melanoma in the skin.

A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.

Inclusion Criteria:

• Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy.
• The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
• Male and female ≥ 21 years old.
• Subject is capable of giving written informed consent.
• Primary excision.

Exclusion Criteria:

• The lesion is less than 1 cm from the eyes.
• The lesion is on the palms of hands or soles of the feet.
• Mucosal lesion.
• Pregnant females.
• Low study procedure compliance.
• Patients who are mentally or physically unable to comply with all aspects of the study.
• Undergoing chemotherapy.
• Minor or legally incompetent and not able to sign the consent form.
• Patient previously tested by MDS and was diagnosed with melanoma during the study.
• Sensitivity to fluorescein