DIAGNOSTIC SYSTEM FOR THE DETECTION OF SKIN CANCER

• US 20090220415A1
• Filed: 12/18/2006
• Published: 09/03/2009
• Est. Priority Date: 12/16/2005
• Status: Active Grant

• Current Assignee: OrLucent, Inc.
• Original Assignee: Amit Shachaf, Catherine M. Shachaf
• Inventors: Shachaf, Catherine M., Shachaf, Amit
• Granted Patent: US 8,642,009 B2
• Time in Patent Office: Days
• US Class Current: 424/1.110
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 2562/166 the sensor is mounted on a specially adapted printed circuit board
• CPC Class Codes: A61B 2576/02 specially adapted for a particular organ or body part
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/416 the spleen
• CPC Class Codes: A61B 5/444 Evaluating skin marks, e.g. mole, nevi, tumour, scar
• CPC Class Codes: A61B 5/445 Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
• CPC Class Codes: A61K 49/0004 Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
• CPC Class Codes: A61K 49/0006 Skin tests, e.g. intradermal testing, test strips, delayed hypersensitivity
• CPC Class Codes: A61K 49/0017 Fluorescence in vivo
• CPC Class Codes: A61K 51/00 Preparations containing radioactive substances for use in therapy or testing in vivo

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.

Claims

1. A non-invasive method for analysis of a skin lesion for the presence of markers associated with neoplasia or tumor angiogenesis, the method comprising:

topically contacting said skin of an individual with a formulation comprising an effective dose of a probe comprising a detectable label, which probe specifically interacts with binds to a neoplasia associated marker;

incubating for a period of time sufficient for transdermal penetration and localization at regions of neoplasia;

illuminating the skin at a wavelength appropriate for image acquisition;

generating an image of localization of the probe in the skin;

wherein localization of said probe to said lesion is indicative of 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.

6. The method according to claim 1, wherein said marker is an integrin and said probe is selected from (i) an antibody and (ii) an integrin binding peptide comprising an RGD motif.

7. The method according to claim 1, wherein said probe is an antibody or fragment thereof.

8. The method according to claim 1, wherein said probe is a peptide, aptamer, peptoid, or nucleic acid

11. The method of claim 1, wherein said the image is generated by fluoresce and captured by film or digital photography of the skin.

14. The method according to claim 1, further comprising forwarding the image to a site for analysis.

4-5. -5. (canceled)

9-10. -10. (canceled)

12-13. -13. (canceled)

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;

a detection unit that receives the light emitted by the surface under investigation to provide a recording of the data; and

an effective dose of a probe comprising a detectable label, which probe specifically binds to a neoplasia associated marker.

18. The system according to claim 15, wherein said formulation comprises an agent that enhances transdermal penetration.

20. The system according to claim 15, 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 neoplasia associated markers.

23. The system according to claim 15, further comprising a mapping module that will map the location coordinates of the mole to a body location.

26. The system according to claim 15, further comprising an envelope containing the address of a location for analysis of binding.

16-17. -17. (canceled)

19. (canceled)

21. A system for analysis of a skin lesion for the presence of markers associated with neoplasia, the system comprising:

a flexible camera; and

a light source selected from (i) a fiber optic bundle to direct the light towards the area of examination and fiber optic net to illuminate the area of investigation or, ii) a light source of LED on a transparent surface.

29. The system of claim 21, wherein the light source is a fiber optic bundle where light traveling in the fibers leak towards the surface of examination.

22. (canceled)

24-25. -25. (canceled)

27-28. -28. (canceled)