Pilot Study to Determine Feasibility of Benign and Malignant Skin Lesion Detection.

N/ACompletedNCT02009085

Orlucent, Inc126 enrolled

Overview

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.

Images acquired in the study are used for the development of a software analysis program.

Study Type

OBSERVATIONAL

Enrollment

126

Conditions

Skin Lesions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Correlation between imaging and pathology.

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.

Time frame: No long term follow up is necessary.

Secondary Outcomes

Acute response

The acute dermal response to the imaging procedure is evaluated.

Time frame: up to 1 day

Data from ClinicalTrials.gov

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