Diagnostic system for the detection of skin cancer

Inventors

Shachaf, Catherine M. • SHACHAF, Amit

Assignees

Orlucent Inc

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Publication Number

US-8642009-B2

Patent

Publication Date

2014-02-04

Expiration Date


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.

Core Innovation

The invention relates to a non-invasive method for analysis of a skin lesion of an individual for the presence of a melanoma having a Breslow thickness of less than one millimeter. The method uses a topical formulation that includes an RGD peptide comprising a detectable label, wherein the peptide specifically binds to an integrin, and a skin penetration enhancer to support transdermal penetration of the peptide and localization in a region of the skin lesion if the integrin is present.

After incubation on the region of skin for a period of time sufficient for transdermal penetration and localization, the region of skin is illuminated with light at a wavelength appropriate for image acquisition. The invention generates an image of localization of the peptide in the region of skin, and localization of the peptide to the region of the skin lesion is indicative of melanoma.

The disclosed approach includes optional controls and device configurations supporting fluorescence imaging and lesion mapping. The topical fluorescent probe is detected via a compact illumination unit and a detection unit, with examples including a flexible camera device with illumination and fluorescence excitation/emission filters and an alternative fluorescence cube combined with a digital camera.

Claims Coverage

The partial content includes one independent claim directed to a non-invasive imaging method for melanoma detection (Breslow thickness < 1 mm) using a topical RGD peptide formulation with a defined skin penetration enhancer, followed by illumination and image generation to indicate melanoma.

Non-invasive melanoma indication by topical RGD peptide localization

A non-invasive method for analysis of a skin lesion comprising topically contacting skin with a formulation containing an effective concentration of an RGD peptide comprising a detectable label, wherein the peptide specifically binds to an integrin and is provided in a topical formulation containing a skin penetration enhancer selected from sulphoxide, azone, pyrrolidone, alcohol, glycol, surfactant, and terpene; incubating for transdermal penetration and peptide localization in the lesion if the integrin is present; illuminating with light at a wavelength appropriate for image acquisition; generating an image of localization; wherein localization is indicative of melanoma.

Overall, the claim coverage centers on using a topical, integrin-binding, detectable-label RGD peptide formulation with a specified skin penetration enhancer, incubating to achieve localization in a melanoma-associated lesion, and using wavelength-appropriate illumination to generate an image whose peptide localization indicates melanoma.

Stated Advantages

Enables non-invasive analysis of a skin lesion for the presence of melanoma having a Breslow thickness of less than one millimeter.

Documented Applications

Non-invasive skin-cancer diagnostic imaging for detecting melanoma by topical delivery of an RGD peptide and fluorescence-based image generation indicative of melanoma.

Lesion mapping and follow-up using a mapping module with body coordinate LEDs/laser to track and archive lesion locations.

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