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

Orlucent

Status: Completed

Conditions: Skin Lesion

Treatments: Device: MDS

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02193581

OMS 001_HMO

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Suspicious skin lesions.

Description:

Patients with a suspicious skin lesion referred for a biopsy are tested using MDS

Treatment:

Device: MDS