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OpenTrials
Completed

NCT Number: NCT02193581

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

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

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Key information

Conditions

Skin Lesion

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hadassah Medical Organization

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MDS

Device

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

Primary outcomes

  1. The MDS produces a score between 1 to 10.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Orlucent, Inc

Industry

Collaborators

  • Hadassah Medical Organization

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2014
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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