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.

Study Overview

• Status: Completed
• Conditions: Skin Lesion
• Intervention / Treatment: Device: MDS

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion excision.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspicious skin lesions.; Patients with a suspicious skin lesion referred for a biopsy are tested using MDS	Device: MDS; Patients with a suspicious lesion, referred for a biopsy is tested using MDS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Collaborators and Investigators

• Sponsor: Orlucent, Inc
• Collaborators: Hadassah Medical Organization
• Investigators: Principal Investigator: Sharon Merims, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: OMS 001_HMO