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

Completed

• Conditions: Skin Lesion
• Interventions: Device: MDS

• Registration Number: NCT02193581
• Lead Sponsor: Orlucent, Inc

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-17
• Study Start: 2017-08-30
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspicious skin lesions.	MDS	Patients with a suspicious skin lesion referred for a biopsy are tested using MDS

Primary Outcome Measures

Name	Time	Method
The MDS produces a score between 1 to 10.	28 days	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.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel