Diagnostic System for the Detection of Skin Cancer

Abstract

Methods and compositions are provided for the analysis of skin surfaces to determine the presence of neoplastic tissue. In the methods of the invention, a composition comprising a florescent probe that binds to a specific neoplasia associated marker is applied topically to the area of interest. After topical administration, the probe preferentially binds to markers associated in neoplastic lesions in situ, which binding is detected with a compact illumination unit that provides illumination at a wavelength appropriate for image acquisition. The illumination unit comprises a light source and fiber optic bundle to direct the light towards the area of examination. A detection unit is used to capture and record an image of the area of investigation. The detection unit may be a digital camera, film camera, etc. A mapping module may also be provided to catalogue the site of examination.

What is claimed is: 
     
         1 . A non-invasive method for analysis of a skin lesion for the presence of markers associated with neoplasia, the method comprising:
 topically contacting said skin with a formulation comprising an effective dose of a probe comprising a detectable label, which specifically interacts with a neoplasia associated marker;   detecting the binding of said label by imaging;   wherein binding of said probe to said lesion is indicative of markers associated with neoplasia.   
     
     
         2 . The method according to  claim 1 , wherein said detectable label is a florescent molecule, a dye that changes color upon activation, or a radioactive isotope. 
     
     
         3 . The method according to  claim 1 , wherein said formulation comprises an agent that enhances transdermal penetration. 
     
     
         4 . The method according to  claim 3 , wherein said agent is DMSO. 
     
     
         5 . The method according to  claim 1 , wherein said marker is selectively expressed on neoplastic cells or selectively expressed on cells associated with tumor angiogenesis. 
     
     
         6 . The method according to  claim 5 , wherein said marker is an integrin. 
     
     
         7 . The method according to  claim 5 , wherein said probe is an antibody or fragment thereof. 
     
     
         8 . The method according to  claim 5 , wherein said probe is a peptide, aptamer, peptoid, or nucleic acid 
     
     
         9 . The method according to  claim 8 , wherein said probe is an integrin binding peptide comprising an RGD motif. 
     
     
         10 . The method according to  claim 2 , wherein said detectable label is a fluorescent moiety. 
     
     
         11 . The method of  claim 10 , wherein said imaging comprises fluorescent photography of said skin lesion. 
     
     
         12 . The method according to  claim 11 , wherein said photography is film photography. 
     
     
         13 . The method according to  claim 11 , wherein said photography is digital photography. 
     
     
         14 . The method according to  claim 1 , wherein said imaging generates an image of said lesion, and wherein said image is forwarded to a site for analysis of said binding. 
     
     
         15 . A system for analysis of a skin lesion for the presence of markers associated with neoplasia, the system comprising: a compact illumination unit that provides illumination at a wavelength appropriate for image acquisition of a fluorescent probe; and a detection unit that receives the light emitted by the surface under investigation to provide a recording of the data. 
     
     
         16 . The system according to  claim 14 , further comprising a formulation for topical use comprising an effective dose of a probe comprising a detectable label, which specifically interacts with a neoplasia associated marker. 
     
     
         17 . The system according to  claim 15 , wherein said detectable label is a florescent molecule, a dye that changes color upon activation, or a radioactive isotope. 
     
     
         18 . The system according to  claim 15 , wherein said formulation comprises an agent that enhances transdermal penetration. 
     
     
         19 . The system according to  claim 16 , wherein said agent is DMSO. 
     
     
         20 . The system according to  claim 14 , further comprising a receiving means for receiving signals from one or more testing devices for reading and displaying for providing indications of the presence of neoplastia associated markers. 
     
     
         21 . The system according to  claim 14 , wherein said detection unit is a flexible camera. 
     
     
         22 . The system according to  claim 14 , wherein said detection unit is a digital camera. 
     
     
         23 . The system according to  claim 14 , further comprising a mapping module that will map the location coordinates of the mole to a body location. 
     
     
         24 . The system according to  claim 14 , wherein said illumination unit comprises a light source a fiber optic bundle to direct the light towards the area of examination and fiber optic net to illuminate the area of investigation. 
     
     
         25 . The system according to  claim 15 , wherein said illumination light comprises a light source and a printed LED net. 
     
     
         26 . The system according to  claim 15 , further comprising an envelope containing the address of a location for analysis of binding. 
     
     
         27 . The system according to  claim 26 , wherein a specific identification number is provided. 
     
     
         28 . The system according to  claim 27 , wherein the specific identification number is a bar code and corresponding case number.