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

Skin Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193581
• Other study ID #: OMS 001_HMO
• Status: Completed
• Phase: N/A
• First received: July 8, 2014
• Last updated: February 14, 2018
• Start date: August 30, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: February 2018
• Source: Orlucent, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Skin Lesion

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Orlucent, Inc	Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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