Page 36 - Noninvasive Diagnostic Techniques for the Detection of Skin Cancers
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Description of Technique
                   Topical application of ALA has been shown to produce increased concentration of
               endogenous protoporphyrin IX (PpIX), which has high fluorescent yield. 109  Studies have shown
               that PpIX accumulates in skin tumors at a much higher concentration than in normal skin. 103,110


               Theoretical Advantages
                   To enhance differentiation between normal skin and tumor, shorter exposure times to ALA
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               have been shown to be promising.  Newer lipophilic derivatives of ALA have been shown to
               increase local bioavailability of these agents and may extend the clinical application of PDD. 112
               PDD may be helpful in guiding biopsies, especially in anatomically difficult sites (e.g., nose,
               ear), 111  and aid in preoperative planning, although the evidence for this claim is mixed. 113-116
               PDD also may be useful in detecting recurrences or multifocal disease. 117  Application of ALA or
               other prodrugs has been shown to be especially useful in detecting BCC and SCC.

               Theoretical Disadvantages
                   The use of PDD in melanoma detection has been less promising than in the
               nonmelanomatous lesions, because it may not have sufficient good sensitivity and specificity in
               detecting the disease, when compared to biopsy. Chwirot 1998, reporting on 90 known
               melanomatous lesions, detected only an 82.5 percent sensitivity and a 78.6 percent specificity
               using autofluorescence. 118  In a 2008 review, Allison and Sibata conclude that the application of
               PDD to melanoma is still “a work in progress.” 119  Recent techniques using laser-induced melanin
               fluorescence have been shown to differentiate malignant melanoma from benign lesions. 120
               Ultraviolet photography, described below, also relies on the fluorescent properties of melanin.

               Variations of Technique
                   •  Ultraviolet light photography. Ultraviolet light is absorbed by melanin. The theory behind
                       this experimental technique is that illumination by ultraviolet light could reveal irregular
                       pigment distribution, and therefore could be useful in defining the borders of melanoma
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                       (e.g., lentigo maligna melanoma).  It is unclear how widespread the use of this technique
                       is in the dermatology community, as we did not identify any other abstracts related to this
                       technique as used in the detection of melanoma.
                   •  Polarized light photography. This method relies on the fact that reflected light has two
                       components—one regular reflectance to reflect the skin surface morphology, the other
                       “back-scattered” from within the tissue. 121  It is useful in the assessment of skin surface
                       morphology when the proper polarizing filters and techniques are used. It can be used in
                       the assessment of dermal melanosis. It is not widely used for assessing skin pigmentation;
                       Taylor 2006 and others have highlighted the limitations of polarized light photography in
                       darker skinned persons with Fitzpatrick skin types IV, V, and VI. 22,121
                   •  Other topical therapies, principally used in the treatment of nonmelanomatous skin
                       cancer, such as imiquimod and 5-FU could be used in combination with photography to
                       highlight skin cancers.

               FDA Status
                   No information was found on the FDA clearance status for the devices of this type on the
               FDA CDRH database for use in the diagnostic evaluation of skin lesions.





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