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

N/ACompletedNCT02193581

Orlucent, Inc50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Skin Lesion

Interventions

MDSDEVICE

Patients with a suspicious lesion, referred for a biopsy is tested using MDS.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Hadassah Medical Organization

Jerusalem, Israel

Outcomes

Primary Outcomes

The MDS produces a score between 1 to 10.

The score is a composite of the images of the mole, plus demographic and clinical information. The score is ranked from 1 to 10, with 1 being the lowest risk for melanoma, and 10 being the highest risk.

Time frame: 28 days

Data from ClinicalTrials.gov

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