Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging
Completed
- Conditions
- Skin Lesion
- Registration Number
- NCT02193581
- 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
- 50
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The MDS produces a score between 1 to 10. 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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie MDS fluorescence imaging for melanoma detection?
How does MDS compare to dermoscopy and biopsy in melanoma diagnostic accuracy?
Are there specific biomarkers that enhance MDS performance in melanocytic lesion evaluation?
What adverse events are associated with topical fluorescence reagents in dermatological imaging?
What are the competitive non-invasive melanoma detection technologies developed by Orlucent, Inc?
Trial Locations
- Locations (1)
Hadassah Medical Organization
🇮🇱Jerusalem, Israel
Hadassah Medical Organization🇮🇱Jerusalem, Israel