Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging
Completed
- Conditions
- Skin Lesions
- Registration Number
- NCT02056522
- Lead Sponsor
- Orlucent, Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 357
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To validate the performance of MDS 28 days
- Secondary Outcome Measures
Name Time Method To calculate and specify the PPV and NPV of the MDS for melanoma detection when used as an adjacent tool to visual skin examination. 28 days
Trial Locations
- Locations (2)
Clalit Health Services
🇮🇱Kiryat Bialik, Israel
Ziv Medical Center
🇮🇱Zefat, Israel