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Completed

NCT Number: NCT02056522

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 Lesions Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

21 year–97 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clalit Health Services, Kiryat Bialik, Israel

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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.

Treatment and study plan

Primary outcomes

  1. To validate the performance of MDS

    Time frame: 28 days

Secondary outcomes

  1. To calculate and specify the PPV and NPV of the MDS for melanoma detection when used as an adjacent tool to visual skin examination.

    Time frame: 28 days

Other outcomes

  1. To further establish the safety of the MDS.

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Orlucent, Inc

Industry

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
2016
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2014
Registry last updated
Nov 18, 2020

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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