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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056522
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Orlucent, Inc

Study Description
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Brief Summary:
The use of MDS to access the presence of melanoma in the skin.

Condition or disease
Skin Lesions

Detailed 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.
Study Design
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Study Type : Observational
Actual Enrollment : 357 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System)
Actual Study Start Date : July 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Groups and Cohorts
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Group/Cohort
Suspicious skin lesions.
No intervention is administered.


Outcome Measures
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Primary Outcome Measures :
  1. To validate the performance of MDS [ Time Frame: 28 days ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. To further establish the safety of the MDS. [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 97 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion excision.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056522


Locations
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Israel
Clalit Health Services
Kiryat Bialik, Israel
Ziv Medical Center
Zefat, Israel, 13100
Sponsors and Collaborators
Orlucent, Inc
Investigators
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Principal Investigator: Shokrey Kassis, MA Head of Plastic Surgery
More Information
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Responsible Party: Orlucent, Inc
ClinicalTrials.gov Identifier: NCT02056522    
Other Study ID Numbers: OMS 001
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Orlucent, Inc:
Melanoma
Skin Cancer
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas