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

Orlucent

Status: Completed

Conditions: Skin Lesions

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02009085

KH 2012

Details and patient eligibility

About

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.

Full description

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

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

126 participants in 1 patient group

Individuals undergoing skin excision.

Description:

Skin lesions are under suspicion for skin cancer.