Status:
COMPLETED
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging
Lead Sponsor:
Orlucent, Inc
Collaborating Sponsors:
Hadassah Medical Organization
Conditions:
Skin Lesion
Eligibility:
All Genders
21+ years
Brief Summary
The use of MDS to access the presence of melanoma in the skin.
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02193581
Start Date
August 30 2017
End Date
December 1 2017
Last Update
February 19 2018
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel