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

NCT02193581 | Completed DMC

• 1 other identifier: OMS 001_HMO
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Lesion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Suspicious skin lesions.

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

Device: MDS

Interventions

MDS DEVICE

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

Suspicious skin lesions.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Orlucent, Inc: lead
• Hadassah Medical Organization: collaborator

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Study Officials

• Sharon Merims, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 17, 2014
• Study Start: August 30, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

IL (1)