Pilot Study to Determine Feasibility of Benign and Malignant Skin Lesion Detection.
Completed
- Conditions
- Skin Lesions
- Registration Number
- NCT02009085
- Lead Sponsor
- Orlucent, Inc
- Brief Summary
In this study a fluorescent contrast dye is applied to a suspicious skin lesion.
Images are acquired and processed. The information is used to develop a prediction model for the presence of malignant transformation in the skin.
- Detailed Description
Images acquired in the study are used for the development of a software analysis program.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
Inclusion Criteria
- Over the age of 18
- Individual is scheduled for a skin biopsy in toto
- The lesion is pigmented or non pigmented
- Lesions may be under suspicion for basal cell carcinoma, squamous cell carcinoma, actinic keratosis, nevi, melanoma, seborrheic keratosis.
- The lesion is accessible to the imaging device
Exclusion Criteria
- The patient has sensitive skin and easily breaks out in rash
- The lesion is within 1 cm of the eye
- The lesion is on mucosal surfaces (e.g., lips, genitals)
- Pregnant females
- Taking medications that pigments the skin
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between imaging and pathology. No long term follow up is necessary. Patients are imaged and then undergo a biopsy. Images are used to develop a software predicting model based on pathology. Sensitivity and specificity parameters are calculated.
No long term follow up is required since the biopsy is performed on the skin imaged. The follow up required is for the pathology for the skin excised.
- Secondary Outcome Measures
Name Time Method Acute response up to 1 day The acute dermal response to the imaging procedure is evaluated.