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

Skin Lesions 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: NCT02056522
• Other study ID #: OMS 001
• Status: Completed
• Start date: July 2016
• Est. completion date: July 2018

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: 357
• Est. completion date: July 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 97 Years

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.

Related Conditions & MeSH terms

• Melanoma
• Skin Lesions

Locations

Country	Name	City	State
Israel	Clalit Health Services	Kiryat Bialik
Israel	Ziv Medical Center	Zefat

Sponsors (1)

Lead Sponsor	Collaborator
Orlucent, Inc

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To further establish the safety of the MDS.		28 days
Primary	To validate the performance of MDS		28 days
Secondary	To calculate and specify the PPV and NPV of the MDS for melanoma detection when used as an adjacent tool to visual skin examination.		28 days