Pilot Study to Determine Feasibility of Benign and Malignant Skin Lesion Detection.
This trial is active, not recruiting.
|Collaborator||Clalit Health Services|
|Start date||June 2013|
|End date||June 2017|
|Trial size||126 participants|
|Trial identifier||NCT02009085, KH 2012|
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.
Skin lesions are under suspicion for skin cancer.
Correlation between imaging and pathology.
time frame: No long term follow up is necessary.
time frame: up to 1 day
All participants at least 18 years old.
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
|Official title||Pilot Study to Asses the Identification of Melanoma in Skin Lesions.|
|Principal investigator||Yehuda Ullmann, MD|
|Description||Images acquired in the study are used for the development of a software analysis program.|
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