Page 25 - Noninvasive Diagnostic Techniques for the Detection of Skin Cancers
P. 25

FDA Status
                   The cameras used during total body photography are not considered medical devices. They
               are therefore not regulated by the FDA. Similarly, the imaging systems used to store, analyze,
               and transmit images are not under the FDA purview.


               Summary
                   Overall, photography included 7 abstracts from 6 unique RCTs—accounting for 64 percent
               of all RCTs included in this technical brief (Appendix D, Table D1). The RCTs evaluated
               outcomes including diagnostic accuracy, excision rates, patient satisfaction, cost savings and
               treatment adherence and followup (Appendix D, Table D1). Outcomes were measured at both
               the patient level (5 trials) and provider level (2 trials), with study participant numbers ranging
               from 88 to 5784. Almost all of the trials were conducted in a primary care setting (2 in the
               United States); only one was set in dermatology. Four of the RCTs were conducted outside of the
               U.S.: 3 in Australia, 1 in the United Kingdom. Abstracts from non-randomized studies consisted
               of mostly comparative and non-comparative cohorts (47 percent)—the remaining abstracts
               included review articles and data from diagnostic test studies. We found that the use of
               photography to capture suspicious skin lesions of the entire body for monitoring purposes is
               commonly used in dermatology practices, but not typically in a primary care setting.
               Photographic surveillance is recommended for patients at high risk of skin cancer, based on
               family history, history of dysplastic nevi, or history of prior malignant lesions. 48,49  However, the
               age of onset and frequency at which it should be performed is unclear. The affordability and
               adaptability of digital imaging permit the increased ease of electronic image storage and allow
               for side-by-side comparisons at future visits. The evolution of computerized imaging systems has
               also enhanced the ability to convey these lesions from patients to providers and across provider
               types. The available data are limited on the role of photography in changing clinical outcomes,
               including confirmation that baseline photographs in specialty clinics improve the detection of
               melanoma, resulting in detection of earlier stage lesions or recurrent lesions. While there are
               some studies, principally from Australia, addressing the impact of photography in primary care
               settings, no similar studies have been conducted in the U.S. Furthermore, data are limited on the
               role of photography for specific racial/ethnic groups. No current trials on photography were
               found in ClinicalTrials.gov.

               Dermoscopy

                   Dermoscopy shows subsurface structures of the skin with the use of handheld devices that
               extend optical light ray penetration beyond the skin surface and minimize surface reflection. In
               contrast, naked eye examination limits visualization of certain skin structures because the
               stratum corneum has reflective properties.

               Available Literature
                   The majority of the included abstracts addressed dermoscopy (69 percent) (see Appendix D,
               Table D1). Our search identified 433 abstracts on dermoscopy from the following types of
               studies: 3 trials, 39 comparative cohort studies; 96 noncomparative cohort studies/case series; 52
               diagnostic test reviews/studies; 49 case reports; 78 narrative reviews; 5 systematic reviews; 74
               technical reports; 37 guidelines, opinion pieces, or commentaries, and others. Of these, 324
               abstracts provided information on the type of malignancy studied; 238 on melanoma, 22 on





                                                             16
   20   21   22   23   24   25   26   27   28   29   30